8/24/2026

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Good morning and good evening to our global investors. Thank you for joining InnoCare Pharma 2026 Entrant Results. This is Li Chenfeng from China Healthcare from Goldman Sachs. We saw today an InnoCare management team including Dr. Jasmine Cui, the chairlady and CEO, Dr. Xiangyang Chen, the CTO, Mr. Xinfu, CFO, Dr. Renbing Zhao, Senior VP of Clinical Development, Dr. Carrie Zhou, VP of Medical Research, Dr. Jason Jiang, VP of Translational Research, and Ms. Bonnie Yuan, Senior Director of IR. Before we kick off the session, I would like to highlight that this call is strictly for clients of Goldman Sachs and anal care only, and this conversation is not intended for the media and is off the record. Participants will be removed from the call if they cannot be properly identified. And this call is not for the purpose of sharing or receiving the public or otherwise confidential information. Attendees are public side market participants who may not receive and should not request non-public otherwise confidential information about issuers or securities or about the market of securities. And okay, I just put out the results a couple of hours ago. And today we're going to have the management team to discuss the business updates and first-half results. After the prepared remarks, you do get a chance to ask questions. So if you have any questions, please feel free to raise your hand, or you can key in your questions into the Q&A box in the Zoom app. Now, without further ado, I'm going to turn the call to the management team to get started.

speaker
Dr. Jasmine Cui
Chairlady and CEO

Okay. Thank you, Siyi. Good morning, good evening. Thank you all for attending Unicare Pharma's 2026 first half year audience call. Unicare is a commercial state drug innovation company. Our vision is to become a global pharmaceutical leader dedicated to developing and delivering innovative therapies for patients worldwide. Our drug innovation efforts focus primarily on two therapeutic areas with significant embedded medical needs oncology and autoimmunity diseases Here are the key business and financial highlights of the first half of 26 In the first half of 26 we delivered strong financial performance while making significant progresses across our diversified innovative portfolio On the financial side Total revenue reached RMB 1.14 billion, representing 55.5% year-over-year growth. Drug sales reached RMB 918 million, up 43.2% year-over-year, reflecting continued strong commercial momentum. Net profit reached RMB 240 million, demonstrating sustained profitability and continued earnings growth. As of the end of June this year, we maintained a solid cash position of approximately RMB 8.4 billion, providing ample resources to support ongoing R&D and globalization. On the R&D front, we made a broad This progresses across our pipeline. We obtained one ADL protocol for aralabronib in RMCL in Australia and submitted two additional NDAs for aralabronib in ITT and zuratractinib in ATR-tel-positive pediatric patients. Two Phase III studies met primary endpoints for sulfasitinib in atopic dermatitis and Fay-Diokra-based kidneys in psoriasis. We also initiated the three new phase III studies, including aronabronid in SLE, mesutoclax plus aronabronid in RMTL, and mesutoclax plus EZE versus vanillotox plus EZE in first-line AML. In addition, we achieved two important proof-of-concept milestones with soft kidneys in vitiligo achieving its primary endpoint and our B7H3 ADC program showing promising preliminary efficacy. Finally, we have filed four INDs this year with the three already advancing into clinical development. Turning to our oncology portfolio, we continue to strengthen both hemato-oncology and solid tumor franchises with multiple commercial products and key clinical milestones. In comatose oncology, arolabranib continues to expand its commercial and global potential. In China, the first-line CLLSL indication was approved and included in the ARDL. In overseas, arolabranib was approved in RRMCL in Australia following its previous approval in Singapore for RRMCL and MZL. Tabacizumab is entering its first full year of commercial sales in China for RRDLDCL further strengthening our commercial portfolio. The digital collapse continues to advance across multiple hormonal logical malignancies. In Phase 3 Registrational Study with Rolacronib for first-line CLL-SL, phase duration treatment is progressing well, with completion expected in the first half of 2017. We have also initiated the Phase 3 Study in RMCL, received Registro Authority destination for RMCL, and are initiating Phase 3 Head-to-Head Study of methadoclax-class AZA versus venetoclax-class AZA in elderly and affixed patients with newly diagnosed AML. The global physical study in MDS is ongoing with promising preliminary results. In solid tumors, suratracnib has established a commercial foundation in ATRK positive tumors with pediatric expansion progressing through priority review of ADC-88. Our next-generation ADC portfolio is also progressing rapidly. Our ICP-B794, our B7-H3 ADC, is in phase 1 dose escalation with promising preliminary results, while ICP-B208, our CDH-70 ADC, has entered the phase 1 dose escalation. We are also pleased to introduce a new bispecific ADC project, ICD-B381, a PSMA Step 1 ADC with potential applications in prostate cancer. The China IND was submitted and accepted in August, with the U.S. IND filing expected in September. Together, these programs are expanding our oncology portfolio from established commercial products into multiple differentiated next-generation assets, supporting our rapid and continued growth across pharmacological and solid tumors. Turning to our autoimmune disease portfolio, we are advancing a broad and increasingly differentiated pipeline toward commercialization while building the next wave of innovative assets with first-in-class potential. On the latest stage size, Arolabronib continues to expand across multiple autoimmune indications. The NDA for ITT was accepted in the first half of this year, while the Phase III registration study in SLE is ongoing following promising phase IIb results. We are also advancing global Phase III PTMS and STMS in collaboration with Zenos Biopharma. So, for this teenage, our TIK2J1 inhibitor continues to advance across a broad five-indication portfolio. In a topic of dermatitis, the Phase III study met its primary endpoints, with any examination planned following the safety follow-up. In vitiligo, the Phase II study met its primary endpoints and advanced into Phase III. Meanwhile, the Phase II studies are progressing in TN, TSU, and cirrhosis, with data readouts expected by later this year for the last two indications. Pseudocoral-based kidneys, our allosteric PIK2 inhibitor, has also reached an important milestone this year. The Phase III registration study in cirrhosis methods primary endpoints with physical study in CLE and Sjogren's syndrome are going. Beyond our latest stage portfolio, we are building a new generation of differentiated autoimmune disease assets. ICD-054 is an oral IO17 inhibitor designed to provide differentiated alternatives to injectable biologics. Greater China and South Asia rights has been partnered with Zenos and the phase 1 completion is expected by end of this year ICD-538 is potentially first-in-class VEV1 molecular glue degrader targeting a novel immune regulatory pathway its phase 1 study is expected to complete by end of this year as well Overall, our autoimmune disease portfolio is progressing in two fronts, advancing multiple later stage projects toward commercialization, while building a differentiated next wave of innovative assets with significant long-term potentials. This slide presents our robust and innovative pipeline, spinning from preclinical through stage one, two, and Registrational State. Currently, we have more than 10 Phase III registration studies ongoing in China and in global. Over the next two to three years, multiple major products and large indications are expected to reach regulatory milestones, further expanding patient access and creating value for our investors. Now, I invite Our CFO, Xianfu, to share more details of our financial and commercial performance.

speaker
Mr. Xinfu
CFO

Okay, thanks, Jasmine. Hello, everyone, and thank you for joining us today. In the first half of 2026, InnoCare delivered very strong financial performance and continued to beat our expectations. The total revenue achieved RMB 1,137 million, representing a 55.5% increase year-over-year. This robust growth demonstrated our commercial execution capabilities, diversified approved product portfolio, and expanding global footprint. The drug sales remain our primary revenue source, reaching RMB 918 million. This accounts for about 80.7% of total revenue, representing a 43.2% year-over-year growth. This growth was fueled by the indication expansion of Aurelia Botany for the first line CLLSL, the new launch of PapacityMap and the Zoolog TrackName, and the strength of our commercial platform, which underscored our transition into a diversified, multi-products pharma company. In the first half of 2026, we maintained our probability trajectory. Net profit turned to RMB 240 million compared to a loss of RMB 36 million in the same period of the last year. The diluted earning per share for the first half of 2026 reached RMB 0.14. This performance reflects our strong top-line growth combined with this clean cost management. And with further growth in drug sales, and the realization of BD-related milestone revenue in the second half of this year. We expect to maintain probability for the full year of 2026, and the EPS will be higher than the first half of 2026. We continue to invest meaningfully in our future. R&D senses reached RMB 497 million with 10.5% year-over-year growth. This investment focuses on advancing late-stage clinical programs and building next-generation platforms such as ADC and molecular growth technologies. Our cash position remains very strong. As of June 30, 2026, cash and related accounts totaled around $1.2 billion. Additionally, we achieved a positive operating cash flow in the first half of 2026. This strong liquidity provides the flexibility to accelerate clinical development and invest in a competitive pipeline. Regarding the commercialization, entering into 2026, we already have three commercialized products. With the new indication approval of Orelabutinib and the launch of the TAPACINAMAB, we have strengthened our leadership in hematology oncology. We now cover four major indications, CL and SL, MCL, MCL and DLBCL. The Orelabutinib and TAPACINAMAB are recommended in the CISCO guideline for eight indications. Zolotragnib, a next-generation Our commercial platform has scaled effectively. A dedicated team of around 500 professionals now cover more than 1,500 hospitals across China. Driven by the continued growth of Orelabunib and the full commercialization of Capacitimab and Azuratracnib, we are confident in 2026 drug sales rose exceeding 35%. In summary, InnoCare delivered a strong financial performance in the first half of this year, with high revenue growth, sustained profitability, and a robust cash relation. So with that, I will hand over to Dr. Zhao for the introduction of programs for the hematology and oncology pipeline.

speaker
Dr. Renbing Zhao
Senior VP of Clinical Development

Thank you, Xin. I'm going to give an update on the field of hematology. We currently have several products, including three that have been launched or in the late stage, phase 3 clinical development. As mentioned earlier, Oralopism has already approved for four indications that has been launched in China. Some of them have been approved or submitted for NDA on the global market. Additionally, we have some phase 3 indications expanding in China and globally. Papacetamab has also been approved for launch last year. And BCL-2 inhibitor, Mesutoclax, has six indications undergoing clinical research expansion in China and globally, and we will discuss in more detail later. Tapacitimab was approved for marketing in mainland China last year, in addition to previously approved in Hong Kong, Taiwan, and Macau. Tapacitimab is potentially the best treatment option for diffuse large B-cell lymphoma in greater China area. Tapacitimab in combination with lenalidomide shows outstanding clinical efficacy, especially for DOR and OS. Compared to the other mechanisms, its efficacy is three to four times longer because of tapacitimab blend combination has triple mechanisms of action. inhibiting B-cells, microphages, and NK cells. This year marks Kappa Thysma's first full year of commercial launch, and we look forward to bringing benefits to more DL-BCL patients in China. Mosutoclax is a novel BCL-2 inhibitor with many clinical advantages compared to a proof BCL-2 inhibitor, Venetoclax. Venetopax has some clinical shortcomings primarily due to a metabolic hotspot in its molecular design and produces major metabolite M27. Within 24 hours, the AUC of M27 is equivalent to 80% of that of Venetopax. M27 has no pharmacological activity. but exhibits hematological toxicities. Both M27 and venetoclax inhibit FIP enzymes and transporters, increasing the drug-drug interaction and posing a significant risk for combination therapies and uncommitted use of medication in clinical settings. The molecular design from the pseudoclax effectively eliminates the metabolites and therefore avoid the amnesia metabolite, resulting in a higher exposure while reducing the hematological toxicity and drug interactions, thus demonstrating an excellent efficacy and safety-profiling clinical practice. As a result, mesutocracts achieved much higher exposure than venetocracts. at 125 mg, mesutopax has three times more exposure compared to menopax at 400 mg. So this slide represents the key clinical data of mesutopax-based regimens across multiple B-cell malignancies covering frontline CLLSLL, BTK inhibitor-treated, Relaxed Refractory MCL. Newly updated results of the Masudoclax plus Aurelaputinib in the Relaxed Refractory MVL and Relaxed Refractory MCL. In the frontline CLL-SLL, Masudoclax in combination with Aurelaputinib yields robust efficacy with 100% ORR57% and a high, very deep MRD-negative rate of 65%. This regimen shows clear advantages over hypotenuse or apalopotenuse plus venetopaxing combination. For the BTK inhibitor treated relapsed refractory MCL, mesutopax monotherapy achieves 84% of ORR, and 36% DRB, demonstrating super rare efficacy versus venetopax and rhodoputinib in this heavily pre-treated patient population. We have also obtained encouraging new clinical results for mesutopax, plasoreloputinib, and two relapsorefractory lymphoma indications. In the RRMZL, the combination delivers 100% ORR and 50% CRE in available patients. Based on the promising data, it has secured a breakthrough designation from CDE for patients with prior treatments of more than one line, and the Phase III IND application has been submitted. In relapsed refractory MCL, Mesutopax Plus shows outstanding anti-tumor activity with 100% ORR and 100% CRE in evaluable patients. Meanwhile, its phase 3 study for relapsed refractory MCL has been approved for initiation in China. Collectively, these multiple indication data validate the broad best-in-class potential of mesutococcus plus orelapidinib, supported by solid clinical outcomes and continuous late-stage pipeline advancement. Beyond lymphoma, mesutococcus also demonstrated compelling strength in AML and MDS. In the treatment of AML, we observed very good data with a composite CRR rate of 81.8% for mesutoplex, which is much better than venetoplex, bisoptoplex, and mesuromplex, especially with the MRD negative rate at 86.5% of all the responders. Not only in terms of the advocacy, but the Stacey advantages are even greater with an SAE rate of only 20.5%, while the other BCL-2 inhibitors range from 40 to over 80%. It also achieved six months OS rate of 90.5%, delivering a significant clinical advantage over the other BCL-2 inhibitors.

speaker
Dr. Jasmine Cui
Chairlady and CEO

inhibitors.

speaker
Dr. Renbing Zhao
Senior VP of Clinical Development

In addition, MDS also, MDS represents a high potential indication with a very large market base. We know the Verano study, the first three trials of venetopax failed in MDS. And so far, no TCO2 inhibitor has been approved for this indication. Our mesutoclax in combination with AZA shows impressive preliminary MDS clinical data with 100% ORR, 40% CR rate, and 16% of marrow CR rate. We maintain a strong confidence in its MDS potential, and the preliminary data has been unveiled in this year's ASCO conference. Overall, mesutoclax exhibits robust and differentiated efficacy across lymphoma, AML, and MDS, highlighting its broad clinical value and promising pipeline prospects. So here we show the pivotal Phase 3 trials in the treatment Naive Ambit-AML. This is a randomized multiple center study comparing the pseudoclax plus azacitidine versus the stand-up cure azavan combination. It involves treatment naive AML patients and fits for intensive chemotherapy. The experimental arm uses contiguous mesutopax at 125 mg QD and the control arm uses venetopax at 400 mg QD with a 5 after the five-week dose escalation. Both arms have a combination with azacitidine. The treatment is given in 28-day cycles until disease progression origin tolerable toxicity. The primary endpoint is OS, and the key secondary endpoints include composite CRV and the MRD next few weeks. In summary, Mosutopax has enormous market potential with a combined market space of over 20 billion U.S. dollars for treating lymphoma to treating leukemia. We believe Mosutopax will be a potential blockbuster asset with a market potential of billions or tens of billions of U.S. dollars and we will advance clinical research with our best effort to expedite its approval and market launch. Now I will hand it over to our Vice President of Medical Affairs, Carrie Zhou, to share the progress in autoimmune disease.

speaker
Dr. Carrie Zhou
VP of Medical Research

Thank you, Ouyang Ding. For autoimmune pipeline, we are very delighted to see that our pipeline has reached multiple key milestones Orilabutinib ITT-ND has been adapted SRE now in the registration phase 3 and TPMS, SPMS also in the phase 3 Sofacitinib ICT332 succeeding on topical metacase phase 3 and vortilagal phase 2 Currently expanding into more indications including varicolabularis, vaticaria and psoriasis The public privacy need for ICT 4.8.8 is authorized this week with the CLE and 16.2.2 initiates. On the early stage front, we have ICT 5.3.8, the first of the very one integrated in China and secondly globally, and ICT 0.5.4, our overall including 17 in hectares, now in Office 1 with our global partner, Chief Gannert, already in place. Collectively, we have built a high-definition and competitive off-week meal pipeline. Aurela Boutinib, also known as the China-trained DTT Integer, is now in the face of TPMs and STMs, which represent over 40% of all MS and more than 12 billion USD commercial opportunities. In ITP, we have the NDA Executive in China addressing 200,000 new patients globally each year. And in SLE, we are the fourth BGK to show the phase 2 advocacy. Now in the phase 3, for 8 million patients worldwide. ICP affects 300,000 chronic patients in China, with 60,000 new cases added every year. Despite available therapies, most patients continue to struggle with relapse and poor quality of life. Patients urgently need a durable, safe, and convenient oral option. That's exactly where Aurela's routine is facing. It directly tackles the root cause of normal B-cell activation and also antibody production. We are offering a well-tolerated one-day LTO designed for long-term use. And we are making real progress. Our NDA has been submitted and accepted by CD, a critical regulatory milestone, while firmly on track to become the next growth driver. SLE is a severe autoimmune disease that affects 8 million people globally, 1 million in China.

speaker
Dr. Jasmine Cui
Chairlady and CEO

mostly young women 15 years of multiple open damage.

speaker
Dr. Carrie Zhou
VP of Medical Research

Translucent SLA treatment including corticosteroids or the immunosuppressants of the biologists. These online needs lack of toxicity, relapse, non-response in many patients, and the inconvenience of injection. Orlogutinib has a highly selective oral BP inhibitor. It has its abnormal B-cell activation and also end-positive reduction with oral convenience. while advancing phase 3 trials with the goal to become the first oral disease inhibitor approved for SLE globally. The global biologics market for SLE already exceeds $3 billion, and with an oral accessible alternative, that opportunity is expected to expand dramatically. We have 22 inhibitors, with two distinct strategies. Supacitinib is a potent addition 1 model, that achieves a strong T2 inhibition with some JAK1 suppression. This program delivers robust synergistic anti-inflammation efficacy across the T pathogenetic pathways, translating into meaningful clinical benefits while steering the JAK2-insured variable-safety process. In parallel, Pharma Ltd. offers auto-selective GH2 banding, with more than 10,000 boards like everything over Jack's family members, providing cleaner mechanisms for chronic use. Together, they still come from the board of a broad oral tech pool for a portfolio designed to address major autoimmune patients. 80% of vaccinations of patients under treatment are slow-to-take effects, and many patients experience inadequate response or even low response at all. Of these two data posts, the particular one tells a different story. You can see that a four-week treatment will achieve the outstanding EZ75 performance, not only exceeding published results for multiple approved drugs at their 12- or 16-week standpoint, and patients' experience directed each relief as early as day two with deep and sustained reduction. Our phase 3 ADH trial run by the double-blind physical control with a 16-week double-blind period and 36 maintenance. At week 15, we met both the co-prime endpoint EZ75 or the IDA001. The maintenance phase is still running and we look forward to seeing the full data. Utilio is more than a skin condition. It carries a profound emotional and social burden for many patients. yet treatment options remain extremely limited. Our Phase II study of subacitinib in vertiligo was a random double-blind, placebo-controlled trial. The primary endpoint change in FVAC from D-blind with transit forward successfully met with positive FVAC, while now advancing to ground-forward Phase III dependence.

speaker
Dr. Jasmine Cui
Chairlady and CEO

This is the result of our Phase II vertiligo study.

speaker
Dr. Carrie Zhou
VP of Medical Research

Subacitinib achieved a 38.8% of FVAP improvement from baseline with 24 with 80mgqd and 41.2% with 120mgqd the highest percentage among all the phase 2 studies of the JAK1 or the JAK3 we are now preparing our end of phase 2 submission to CTE so for CTE group A dual D2, Jaguar Infector, is delivering compelling data across the influential skin disease. In AD, phase 3 met all prime endpoints, and it started in the first half of next year. With the AD market set to grow up from $18 billion to $30 billion by 2030, which level phase 2 was positive, phase 3 now underway, targeting a $3 billion market. Cecil and Soretes' readouts are in England, while also progressing for regulatory in the global system. With multiple capitalists ahead, regulatory failings, typical readouts, and expanding indications, this asset is positioned to capture significant shares from a combined adjustable market approaching $100 billion. In phase 2 trial of Faducarbacitin for psoriasis at week 12, the 9-mgqt group achieved a PC75 response rate, significantly superior to placebo. The p-value is less than 0.001. Responses increased over time, supporting the drug's potent efficacy. This encourages phase 2 data formally supported by Faducarbacitin into the phase 3 trial. In the phase 3 childhood psoriasis, qualified patients were randomized 2 to 1 to receive 9 milligrams once daily or the placebo for 16 weeks, followed by the 36 weeks in attendance. The co-prime endpoint ST75 or STG001 at week 16 were met with robust efficacy, marking a key milestone. Dr. Kovacic's team leverages strong efficacy and safety protocols, unlocking broader market potential. In psoriasis, phase 3 met all prime endpoints, targeting a share of $58 billion psoriasis market, which was back at 214 million patients worldwide. For CLE and certain syndromes, ongoing phase 2 trials address high amendment needs. with a combined market opportunity exceeding $13 billion. Beyond this, our broad platform extends to multiple mutations, representing a total addressable market of over $116 billion. Next, we are delighted to welcome Dr. Chen Xiangyang, who has formally introduced our early stage of the new platform.

speaker
Dr. Xiangyang Chen
CTO

Thank you. In addition to the late-stage molecules, I will introduce two early-stage clinical programs for autoimmune disease. One is VAV1. VAV1 is a pivotal scaffolding protein and signaling molecule downstream of T and B cell receptors. Targeting VAV1 enables modulation of T and B cell functions, offering a new approach of treating autoimmune disorders. including some heart-to-treat indications. Previously, VAB1 was considered undruggable due to lack of small molecule binding parties. Here we develop ICP538, a potent and selective VAB1 molecule multigrader, which is currently in Phase I clinical trial. This slide highlights some preclinical data that they figure shows dose-dependent degradation of AV1 protein with a single-digit nanomolar ICFP. The degradation is rapid and deep, as shown in the middle figure. On the right, the compound demonstrates dose-dependent efficacy and the right CIA model, making the molecule as a promised candidate for further evaluation. Another one is IL-17. IL-17 is a well-validated autoimmune disease target clinically proven by market antibody drugs such as acrocentrics for Novartis with a broad range of approved indications as shown on the right panel. The efficient of IL-17 and receptor interactions can effectively shut down downstream inflammatory signaling. A small molecule, IL-17 inhibitor ICP-CFD4 binds specifically to the IL-17 dimer interface causing sterile interference to binding of dimer by IL-17 receptors. ICP-CFD4 was potent in biochemical and functional assays. has excellent PK property and was dose-dependently efficacious in the in vivo wide-CIA model. The molecule is currently under Phase I clinical development. Over years, we have built a diversified autoimmune disease pipeline, including clinical-state molecules, orevaprotinib, and also others listed here, and preclinical access with multiple modalities, small molecules, biologists, degraders. Our pipeline provides comprehensive coverage of indications in multiple disease areas, dermatology, hematology, neurology, rheumatology with potential expansion into nephrology with unmet medical needs. Next, I turn our hand over to Dr. Chih-Sing Tsang.

speaker
Dr. Jason Jiang
VP of Translational Research

Thanks, Jianan. I will introduce our office, our innovative solid tumor essence. The first in the solid tumors, our first innovative Zulatrap10, which is the second recent TRK inhibitor, was already approved in December last year for the treatment levels as adults and adolescents solely tumor patients with NTRK G-period. So the clinical activity data are very outstanding, with an ORR of 89.1% and a long duration of response. So, in addition, the Zolotaxinib has also demonstrated the ability to overcome resistance to third-generation chair-type users in clean. The NDA for pediatric patients was submitted June 2 this year, and the IRC assessed ORR was 100%, with 10% of fail and 90% of clear, which is particularly remarkable for the pediatric patients with solid tumors. Our ADC platform is one of the key specific pillars of our efforts in biologics for the treatment of polytrums. So we have developed a different ADC platform by optimizing the three key components of ADC, including irreversible connector, hydrostatic linker, and holding payload. So the irreversible connector prevents the non-specific payload exchange. the hydrophilic linker allows high RNA rate and improves the stability and the highly potent payload is selectively released within tumors and shows strong bystander steps and a unique property of our ADT payload is the high clearance rate which helps reduce the systemic constriction directly eliminating the payload from the system The CDH17 ADC is our present ADC moving into the clinical development. CDH17 is a highly permitting party for many gastrointestinal cancers. So in normal tissues, CDH17 is hidden in a tight junction and largely inaccessible. However, in tumor cells, the CDS17 is posed, making it an attractive therapeutic target. So the CDS17 ADC has brought many GI cancers, including colorectal, plastic, and pancreatic cancers. So in the treatment of tumor models with both high and low CDS17 expression, Our CDS-17 EDC shows siliceous elasticity than one of the leading competitors, and the advantage is even more significant in low-expression tumors. So the second study of the CDS-17 EDC B208 is ongoing for the treatment of GI cancers. We have applied our innovative EDC platform into the design of the bioprocessive EDC. So the STIC-1 PSMA EDC is our first bioprocessive EDC moving into clinical development. So by dual targeting of both PSMA and STIC-1, the bioprocessive EDC has the potential to enhance the activities when both candidates are presented. and SHAPE would act even at a low target expression, and all harmed blood regions mediated by loss of E their antigen. To improve single studies, our adaptive agency B3A1 demonstrates robust and dose-dependent in vivo antigen activity. In the in vivo school models with low expression of both antigens, B3-A1 through superior efficacy compared with the leading competitors, which is in the 6.1 study. So in summary, the key advantages of our ADC platform include the high star value, the wide security windows, and the ability to evaluate the last rumors and overcome the resilience. So we are advancing the clinical development of our ADC pipelines rapidly. For the B303 ADC, we have completed 5 growth cohorts for the growth escalation study. There are no DLT results so far, and we are initiating the growth level scale. And we have finished the first dose level of CDS-17-GDC and moving into the second dose level. The AMD of the C1-GFME after EDC has been dominated to DDE and the U.S. AMD signing is detected in the X-Bond. So, I will hand over to Jeffrey.

speaker
Dr. Jasmine Cui
Chairlady and CEO

Sure, yeah, thank you. Finally, let me briefly walk you through our key upcoming Events and Milestones Looking ahead, we expect multiple important clinical and regulatory milestones across our hematology, autoimmune disease, and solid cancer portfolios, further advancing our products toward commercialization and global development. In hemato-oncology, key milestones include the data results and ADA submissions. for the 53-arola-bronid-class methadoclax study in frontline CLL-SLL with a fixed duration regimen, and also the completion and ADA submission of the registration study in BT-10 inhibitor-treated MCL. We also expect further progress of methadoclax across multiple indications, including Phase 3 initiation in RMTL and MZL, and Phase 3 initiation of methadoclase-type ADE versus venetoclase-type ADE in first-line AML, and the completion of global Phase 2 study in MZS, and then advancing to Phase 3. In all the immune diseases, we expect multiple milestones across our portfolio. This includes IETT-ADL profile for Arulagramid, and further advancement of SLE Phase III study and the global TPMS-STM studies with ZENOS. For specific kidney milestones, including ADA submission in atopic dermatitis, Phase III initiation in vitiligo, beta readouts and potentially Phase III initiation in CSU and cirrhosis, and the completion of the global Phase II study in TN. for FasioCore-based kidneys, we expect further progress in cirrhosis, CLE, and Sjogren's syndrome, together with the exploration of additional indications. We also expect the FasioCore compilation data rate out for ICP538, our VEV1 molecule glue degrader, and 0504, our oral IL-17 inhibitor. In solid tumors, We expect development milestones across our ADC portfolio, including completion of dose expansion and establishment of recommended dose for ICP-B794, dose escalation data results and expansion for B208, and IND approval and first patient in both China and in the U.S. for B381, our TSM-A. On the financial side, we expect to sustain profit positive performance throughout 2026, further demonstrating the strength and sustainability of our commercial growth. Overall, we expect the coming period to be marked by multiple clinical and regulatory catalysts across our diversified portfolio. With that, this concludes our presentation. Thank you very much for your time and continued support to InnoCare Pharma. We would now be happy to take your questions.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Thank you, Jasmine, and thank you, management team. This is already more like a mini R&D day, a very comprehensive pipeline update. So now we're going to get into the Q&A session. Any questions, feel free to raise your hand or type your questions into the Q&A box. I'm going to start with two questions, then I'm going to be turning to those who raised their hands. The first question is really about the sales performance, right? In the second quarter, in the first half, it has been very, very strong, and we're still maintaining, we're still giving the guidance of full year 35%. One thing I'm trying to understand a bit more, you know, in the first half, what percentage of the sales process contributed by the new products, which is Taffa, which is Zeta-Charcinib, instead of only, or the percentage driving the growth? That's number one. Number two is, Of course, endocare has been very strong in oncology, particularly hematology and immunology, right? We've already built a very strong pipeline. Now, with the ADT platform, we see more assets in getting to clinics. Now, we already have one at Phase 1. We have a CDH-17, PCMAS-D1, but they're also getting to clinical trials very soon. So, How would you balance the resource allocation among Sonic Humor, Hematology, and also Immunology? That's my second broad question.

speaker
Mr. Xinfu
CFO

Thank you, Lee. Let me answer your questions about the financials. The first one is about the sales performance. At the year beginning, we did have the commercial goal that the total commercial drug sales will exceed 35% and we see the first half performance we have very confident to achieve on that and also the the Aurela we said have the more than 30% growth looking into the first half performance actually we we beat both the target and also the Tapacinab and the Zulacar name actually is the first year for the for the full year for the commercialization The TAPA starting from the private market, the Zola trade game is still not in the national universities. so the the value point of view actually for sure the Aurela book name actually is country of the most from the value point of view is more definitely more than 30 percent growth well from the growth number because there's no base for the TAPA and the solar tracking in the last year actually there even that is very small numbers but the growth rate is very high so this is the We also continue to see that Orilla will continue to grow, especially for this year. We have approved for the first-line CLL and also successfully included in the national reverse list starting from the year beginning. which are already significant to enlarge the addressable patient pool and also the Aurela maintain the advantage for the only one BTK to treat MZL patients. Now with our the commercial footprint expanding we have more deeper penetration so we are very confident and also the first half year 43% growth we are very confident to beat the 35 full year growth rate so for our research allocation I would say the three franchises in a different stage and our chemical oncology late to the cancer is our leading franchise

speaker
Dr. Jasmine Cui
Chairlady and CEO

and we already have two commercial products on arolabronib, tavacitamab. And we see actually muciloclasts with huge potential, particularly in combo with arolabronib and with others. So we definitely will put big efforts and a lot of research money will go into the franchise, especially in clinical trials. So we categorize our chemical oncology as from 10 to 100. For autoimmune disease, we have three phase three products, late stage products, and a number of early stage products. But we don't have a commercial product yet. And with IQT, the profile we officially entering into commercial of autoimmune disease, it's also very important for us. But I would categorize this as like 1 to 10 stage and so we still try to you know get approval and try to do well in our commercialization for solid tumor except Zolatrexanib and it's a very very small indication our project is still early stage and still in the POT stage And I would say that is from zero to one for our solid cancer. So, you know, these three franchises are important for patients, for us as well, and for market size. And this is in a different stage. So we invest into our products. our portfolios in a dynamic way. But at this moment, at the clinical trial, dermatology is our most important, followed by autoimmune disease. And solid cancer will establish a lot of proven concepts for our new project, still not in history yet. And in terms of dollar spending, money spending, probably is less.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Great. Thank you so much. Very clear, Jasmine. Next question is coming from UDS, David Guo. David, please. David, your line is open.

speaker
David Guo
Analyst, UDS

Sorry, can you hear me?

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Yes.

speaker
David Guo
Analyst, UDS

Can you hear me now? Okay, great. Thank you, CEO. and many congratulations to the management for the very strong first half result. So I basically have two questions here. The first one is still regarding the sales. So it looks that we maintained the guidance of the 5% young year growth and may we kindly see any of the reasons behind of this reiteration of the guidance and also if there's any opportunities for example EQ3 to see the potential to raise this guidance and my second question is on the MISO clocks as we're nearly approaching the registrational trials for the MCL and the first line CLL data readout and potential NDA submissions so do we have more colors about the timeline of these and also if we could have more colors on the potential hematology pipeline major data results in the second half, for example, in the ASH or ECMO. Thank you very much.

speaker
Mr. Xinfu
CFO

Alright, so let me answer your first question about the guidance. We have a bid for the guidance both for the ORLA alone and also the overall commercial. Well, we see that several factors we will continue to consider. Firstly, that the We still have a very good penetration for the CLL and still need some time because we just built up the team in the first half of this year and still need some time to build up the connection with how people get drugged in. to the hospital listing. We see that there's accelerates in the rural area. So we will see the situation and to monitor our quarter three performance and then to, you know, if possible, we can raise the free guidance with the quarter three result.

speaker
Dr. Renbing Zhao
Senior VP of Clinical Development

So I'm going to answer the second question regarding the pseudoclax. For the lymphoma indications in the first line, CLLSLL, our Phase III study with Masudu in combination with Orelabutinib, we have already completed the enrollment early this year. And now we're looking at the data readout at the first half of 2027. For the relapsed refractory mental cell lymphoma post-TTK treatment that was a single-arm phase 2 study. We're very close to complete the enrollment very soon, so we're also expecting the data readout early next year for registration. As for the near-term data reviews, we have submitted abstracts for ASH this year, both for the AML and MDS Phase II data, so we're going to have more updates by then.

speaker
David Guo
Analyst, UDS

Thank you. Very clear. Looking forward to the data. Thanks.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Great. Just a reminder, any more questions, feel free to raise your hand. I actually got a couple more questions here. Number one is, it's really trying to understand the authentication progress for Aurela Britannic. The first one is the ITP, because you already filed and did, but... From what I understand, this is a supplemental NDA. So the pharmacology part and CMC part, manufacturing part is pretty much already being cleared and now regular screen really focusing on the clinical data. Then what's going to be the current status of review and when we should be expecting the new indication to get approved for aura? and also for Aura and SLE. My understanding is that the first patient dose was back in April, right? We understand there has been a lot of different drugs competing for lupus indication in China. So in the past four to five months, we try to understand a bit more about the patient enrollment progress and if it's difficult or it's relatively easy to get a patient enrolled in your studies. And lastly, on Aura, we try to get more sense from you guys on Zena's part, which is for two MS indications. Phase 3 are ongoing, right? The PPMS was started first quarter last year, and the first quarter this year, SPMS has been initiated for the Phase 3 studies. So how's the progress of the patient enrollment, and when we're going to potentially see the first set of data coming out?

speaker
Dr. Jasmine Cui
Chairlady and CEO

So, for IAPP, actually, we anticipate the approval. You are right. Actually, the CMC clinical farm is pretty much similar to other indications. We are only, you know, looking at the clinical data approval. So, we anticipate it by first half of next year. and I think the data submitted to ASH and the phase 3 data will show to see that by end of the year for ITT and SLE is progressing pretty well from first patient year to now it's about 4 or 5 months 4 months and we already enrolled a pretty good number of patients and I think as you know there are a lot of SLE patients and the problem is that we follow the CBE's close guidance about the patient's enrollment and we need to really enroll the patients with unmet medical needs and those ones with severe diseases and also we keep our blue corticoid use reduced and we follow a lot of top standards so we are pushing very hard and we hope to finish this is a large study more than 400 patients we are going to push very hard to finish it and with regard to CTMS STMS with Zenos yes they are doing pretty well actually I met with Lonnie in August actually early this month and pretty happy with their progress and they already those you know TTMS enrollment is ongoing STMS you know through a lot of the changes you know the sponsorship from us to them they get registered in Europe and they get the screening patient very aggressively and they get the first patient in to get our milestone and so they are going pretty well so for these two indications actually you need to finish the patient enrollment and they take about a year and a half or two years and then they wait for the data readout and so we need to wait for about three years to know the clinical data.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Got it. Thank you very much. And also for the early stage assets I'm actually pretty interested in Two things. Number one is definitely the VAV1, the 538 you mentioned about. And, of course, this is still, you know, pretty early. I try to understand a bit more about the difference in the molecular design compared to the front runner, which is Novartis acquired from Monterosa. and the 6160. So they are already moving to phase two studies and you guys probably about like six months to 10 months later. So how would you compare your assets to them?

speaker
Dr. Xiangyang Chen
CTO

Yeah, yes. So in terms of molecules are molecules ICP-538 has a slightly different binding mode compared to MRT6160 the molecule explained to a adjacent target so that's not occupied by 6160 so right now the molecule are in the clinical trial and actually the trial Pharma Ltd Pharma Ltd Pharma Ltd a clinical study. So our compound actually is not that far behind Novartis compound.

speaker
Dr. Jasmine Cui
Chairlady and CEO

Yeah, I think I want to add the point. So in the clinic, we already have a dose, like four or five doses, and we don't definitely see differences of the clinical profile of this one. So we're excited about the molecule. and we do feel our compound is efficacious and we feel their product has a good safety profile and so they are exploring sugaring to the single and we are thinking perhaps we explore different indications and again so you know get a molecule to fix one to subside it's just the zero to one and now we start you know the fun part one to ten and the ten to one hundred and which indications we are going to explore great and also for the RL17 I understand it's going to be blocking

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

IL-17 AA and AF, which is more, you know, compared similar to the B. McKee's map as antibody. So how would you position the IL-17 in the clinic, in the clinics, you know, compared to antibodies? Are you targeting to be non-inferior in efficacy, you know, better in safety and convenience, or you're actually really looking at potentially a better one even compared to antibody? And there's another issue is that we're always kind of concerned about the liver toxicity, about developing the oral ones for this one, because we have seen several companies working on RL-107A, SM-108, even they're not really talking to blocking 178F. So they already show, you know, animal model, animal tox didn't show much issues, but when it's getting to the human studies, toxicity has become one of the major issues. So we have seen that kind of failure. How would you position your assets in a clinical setting and now getting into clinics? How would you think about the overall safety profile?

speaker
Dr. Jasmine Cui
Chairlady and CEO

Yeah, right. This is a very good question, Ziyi. And actually with the small molecule and our molecule block effect the A and AF as you pointed out. And so with the oral comparing to biologics injectable, it has a very obvious advantage, right? And it is much convenient for taking by oral. And so in addition to the oral side, And we also expect, you know, this molecule is not inferior with the antibody and in the clinic. With liver toxicity, we think it's compound-based. It's not MOA-based. And so, really, their first compound has a liver, perhaps has a liver issue, their own compound. But currently, their phase 2 compound seems okay for the liver toxicity. So, we watched very carefully on that. And so far, the phase 1 study, and we already finished a few doses. and it looks pretty good. We also finished MAD. We also started MAD, the first dose, and everything looks pretty good now.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Oh, that's great to hear. And also very interesting for the two type 2 inhibitors, the sulfate TNIP and also feta-credivax TNIP, those two molecules are now pursuing very different indications. And I'm actually curious on two things. Number one is about, you know, for those two assets, how would you think about the global clinical development programs? Of course, there have been some phase one, phase two ongoing. But moving to payroll studies, what are the indication, you know, both assets could potentially be targeting? And secondly, it's really about when you are thinking about the indication to pursue for each of the assets, what is the logic behind? How have you decided, you know, which one is going to be covering which indication?

speaker
Dr. Jasmine Cui
Chairlady and CEO

Right. So this is also for the indication. That's where I think actually every day, you know, what we should have for all the different indications. For the first compound, which is traditionally called 332, this is Tick-2 with the Sun-Jack-1 activity in it. And the compound demonstrates excellent efficacy. Anyway, we haven't disclosed too much data yet. It met primary endpoints, and so it looks very good. And since these two together can effectively block a block, immunological pathways. There are so many different pathways in the body, so we know about 10, perhaps more than 20 or more. So the two combined definitely will work much better than TIK2 alarm or JAK1 alarm. So if you imagine this molecule equivalent to a combo of the two mechanisms. So some experts said, well, for JAK1 inhibition, the maximum you can inhibit is like the Jack-1 inhibitor. But the efficacy, we already know in IBD, you reach 50-some percent-ish. And so if you add another player, you do a combo with TIK-2, whether that will increase the seeding, the top seeding, and get a much better result. We saw, I have to say, we saw it in our indications, the Phase-3 and some Phase-2 And we already saw a hint of that's very differentiated from RINVOC, just one inhibitor, and also differentiated from two inhibitors for sure. So we think this molecule is a very broad indication, particularly with patients, you know, with severe disease, field biologics, and other treatments, we think that's the last choice. of the autoimmunity-based drug. So we have a lot of, you know, high hope of potential on the molecule. And globally, we already, you know, finished phase one. We are doing phase two for TN. TN is indicated with, you know, probably the most itching. So it's a very severe, actually, indication. And we should get the phase 2 result. We're finishing the patient enrollment, hopefully soon, and get the results. And from the embryonic result, it looks, you know, very promising. So, and with that, we probably move to phase 3 for TN and globally and with expansion of other indications. So, the first wave indications for this compound are, you know, the five indications in dermatology. And we consider that for commercial purpose and for other, you know, purpose. But the second wave indication definitely will go to much more severe indication like IBD and others. Our ulcerative inhibitor 488. And we finished, well, the primary endpoint for sclerosis. And we are also excited about it. is definitely the second generation of TIK2, allosteric TIK2 inhibitor, the GH2 inhibitor, and it's very different from Ducra. And so we have also, and it has extremely safety profile for the compound, although we have not disclosed all the profile yet. And so we think this will be good to a lot of diseases, and particularly with, you know, We already think like CLE, like Sjogren's, and others, and potentially can be used to combo with other mechanisms if it is so safe. And so we definitely, I think the two compounds, we are discussing a number of indications, and we think the two compounds will cover so many different indications. and if you bought over 100 indications for autoimmune disease, these two compounds cover like 20-30% of autoimmune disease indications. So we're so excited about it. We would like to gradually discuss all our results and indications. I hope you will be as excited as we are about these two compounds.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

Yes, we do. We're definitely looking forward to that, but more data could potentially get us more excited. we're already 15 minutes overrun so my last question is referring to the potential collaboration deals because we remember that at the beginning of the year the company mentioned about this year you guys are already targeting two deals by the end of 2026 now we're at 8 months getting to 9 months so what are the progress

speaker
Dr. Jasmine Cui
Chairlady and CEO

and is there any particular particular assets we are really focusing on to get the deal done yeah this is a very good question to you and so we have the bb you know we have a lot of activities and i came back from the us actually have been many activities on the bb And I think one way for the project, our Phase 3 project, as you mentioned, the Mesutoclax and also the TIK2 inhibitors, the two TIK2 inhibitors. So there, you know, we are being very careful, you know, what kind of partners we are choosing and, you know, of course, what kind of collaboration we want. And another wave of BDDLs will be on the early stage. assets on the, you know, autoimmune disease assets like VV1 and others, not to disclose the target, and also our ADC products and others. And for that, and also, you know, we are discussing. And so, I mean, the GDPR is like, unless you sign it, you close it, And so it's not like, you know, phase one, phase two, phase three clinical trials. You know where you are. And so with Unicare, you know we have a lot of cashes, and we have our strategy for globalization, and we choose our partners very carefully. You know, we are not in an urgent to, you know, get the cash and trade for the cash. So we have our pace. and we do need to choose the right partner. And for example, with Zenos last year, I think we chose that Zenos very carefully. And actually, you know, we are so glad they're doing so well. And we gradually realized all the milestones. This year we already got two or three milestones from them and have a few milestones to go. I think they are doing very well. So for this asset, we are partnering with. And we have been very careful and we have a clear mind of what we want. And so once the deal is closed, we will let you know as soon as possible.

speaker
Li Chenfeng
China Healthcare, Goldman Sachs (Moderator)

For sure. Thank you so much, Jasmine and the team, for the updates. Any final comments to wrap up the call?

speaker
Dr. Jasmine Cui
Chairlady and CEO

Yeah, I mean, thank you all for your support to Unicare. And this year, actually, 26, we have a lot of catalysts. and milestones and then we have full confidence to reach we have continued profitable this year and years afterwards so thank you very much for your attention for your support and we look forward to seeing you in the ADI next week great thank you thank you a nice day yeah good night money

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