Core Insights - InnoCare Pharma presented over 20 studies on its BTK inhibitor orelabrutinib at the 67th Annual Meeting of the American Society of Hematology (ASH) [1] Efficacy and Safety - Orelabrutinib has shown significant efficacy and safety across multiple lymphoma types, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL) [2] - In a study involving newly diagnosed PCNSL, the combination of orelabrutinib, rituximab, and high-dose methotrexate achieved an objective response rate (ORR) of 89.5% and a complete response (CR) rate of 78.9% [4] - The orelabrutinib and obinutuzumab combination demonstrated an ORR of 96.0% in treatment-naïve MZL patients, with no severe toxicities reported [6][5] - Orelabrutinib combined with rituximab showed an ORR of 81.8% and a CR rate of 72.7% in treatment-naïve MZL patients who were unsuitable for local therapy [7][8] - The orelabrutinib plus bendamustine-rituximab regimen showed promising tumor response and survival outcomes in transplant-ineligible, intermediate- to high-risk MCL patients [9] Real-World Studies - A large-scale real-world study in China indicated that R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like DLBCL patients, supporting subtype-directed therapy [11] - Preliminary results from a phase II study suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail DLBCL patients, with a CRR of 77.8% and an ORR of 100% among those completing three cycles [12][13] - A retrospective real-world study indicated that orelabrutinib monotherapy achieved an ORR and disease control rate (DCR) of 100% in CLL patients [14] Future Directions - Additional studies on orelabrutinib have been selected for poster presentation and publication at the 2025 ASH Annual Meeting, indicating ongoing research and development efforts [15]

BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chr ...

Core Insights - InnoCare Pharma presented three studies on its BCL2 inhibitor, Mesutoclax (ICP-248), at the 67th Annual Meeting of the American Society of Hematology, showcasing its efficacy and safety in treating various hematologic malignancies [1][2]. Group 1: Efficacy in Relapsed/Refractory Mantle Cell Lymphoma (MCL) - Mesutoclax monotherapy demonstrated an overall response rate (ORR) of 87.5% and a complete response rate (CRR) of 46.9% in MCL patients, with an ORR of 84.0% and CRR of 36.0% in BTK inhibitor-refractory patients [3][4]. - The drug was well tolerated across all dose levels (50-150 mg), with no dose-limiting toxicities (DLTs) observed, indicating a promising safety profile [4]. Group 2: Efficacy in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - In CLL/SLL patients, both treatment-naive and relapsed/refractory, the ORR was 100% for those receiving 125 mg of mesutoclax, with a 65% undetectable minimal residual disease (uMRD) rate at week 36 when combined with orelabrutinib [5][6]. - Mesutoclax exhibited a tolerable safety profile, with no DLTs reported up to 150 mg QD [6]. Group 3: Efficacy in Acute Myeloid Leukemia (AML) - The combination of mesutoclax and azacitidine (AZA) achieved a composite complete response (CR+CRi) rate of 92% in treatment-naive AML patients, with 82.6% achieving undetectable minimal residual disease (uMR) [7][8]. - The combination therapy was well tolerated, with no DLTs or tumor lysis syndrome (TLS) events reported, and a 90-day mortality rate of 0% [8]. Group 4: Ongoing Clinical Trials - InnoCare is conducting two registrational clinical trials: one for the combination of mesutoclax and orelabrutinib for treatment-naive CLL/SLL, and another for MCL patients refractory to BTK inhibitors [9]. - The clinical study of mesutoclax as a first-line treatment for AML has entered the dose expansion phase globally, and a study for myelodysplastic syndrome (MDS) is being launched [9].

Summary of Zenas BioPharma FY Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Date of Conference**: December 03, 2025 Key Accomplishments in 2025 - Completion of patient enrollment in the Phase III trial for obexelimab targeting IgG4-related disease, with last patient out in November [2][5] - Successful enrollment in a lupus study, with results expected in Q3 of the following year [3][5] - Significant results from the MOONSTONE Global Phase II study in relapsing multiple sclerosis (RMS), showing a 95% reduction in new T1 GAD-enhancing lesions compared to placebo [4][5] - Expansion of the pipeline with the acquisition of orelabrutinib, now in Phase III trials for progressive MS [4][5] - Partnership with Royalty Pharma for a potential $300 million financing related to obexelimab [5] Clinical Trials and Data Insights - The MOONSTONE study involved 116 patients and demonstrated a new benchmark for B-cell targeting agents in RMS [3][4] - Upcoming 24-week data from the MOONSTONE study will provide insights into various parameters, including T1 GAD-enhancing lesions and biomarkers [10][11] - Discussion on regulatory pathways for RMS trials, emphasizing the need for evolving endpoints beyond annualized relapse rates [14] Market Opportunities - Estimated 20,000 to 40,000 diagnosed patients in the U.S. for IgG4-related disease, with a potential market size based on competitive drug pricing exceeding $250,000 annually [23][24] - Observations on the competitive landscape, noting the successful launch of a competing drug with sales growth from mid-$20 million to over $40 million in the first two quarters [25] Future Expectations - Anticipation of Phase II SUNSTONE results for lupus, aiming for a significant difference from placebo [26][27] - Plans to integrate findings from the lupus study into the broader rheumatology franchise [27] Differentiation of Products - Obexelimab is positioned as a more flexible treatment option compared to continuous B-cell depleting therapies, with at-home auto-injector capabilities [20][21] - Orelabrutinib is highlighted as a best-in-class BTK inhibitor, with superior brain penetration and potency compared to competitors [28][29] Conclusion - Zenas BioPharma has made significant strides in 2025, with promising clinical trial results and strategic partnerships that position the company for future growth in the biopharmaceutical market. The focus on innovative treatment options and market opportunities in IgG4-related disease and lupus reflects a strong potential for success in upcoming years.

Core Insights - Zenas BioPharma reported significant advancements in its clinical trials, particularly with obexelimab, which showed promising results in treating autoimmune diseases [1][2][3] - The company has secured substantial funding to support its clinical development and commercialization efforts, including a $300 million agreement with Royalty Pharma [1][6] - Zenas is expanding its product pipeline with the acquisition of three new autoimmune product candidates, including orelabrutinib, which is in Phase 3 development for multiple sclerosis [1][3][10] Clinical Trial Updates - The Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) is set to report topline results around year-end 2025, marking it as the largest clinical trial for this condition to date [1][3] - The Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis (RMS) demonstrated a 95% relative reduction in new gadolinium-enhancing lesions compared to placebo, with a p-value of 0.0009 [3][4] - Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026 [3] Financial Highlights - As of September 30, 2025, Zenas had cash, cash equivalents, and investments totaling $301.6 million, which, along with recent financing, is expected to fund operations into the fourth quarter of 2026 [7][18] - The company reported a net loss of $51.5 million for the third quarter of 2025, compared to a net loss of $38.6 million for the same period in 2024 [13][17] - Research and development expenses for the quarter were $34.4 million, while general and administrative expenses increased to $13.2 million from $7.5 million year-over-year [7][17] Pipeline Expansion - Zenas has entered into a license agreement for orelabrutinib, a BTK inhibitor, granting global development and commercialization rights outside Greater China and Southeast Asia [3][10] - The company is also advancing two additional product candidates, ZB021 and ZB022, both of which are expected to enter Phase 1 clinical development in 2026 [4][10] Company Overview - Zenas BioPharma is focused on developing transformative therapies for autoimmune diseases, with a strategy that includes acquiring and developing product candidates that offer superior clinical benefits [11] - The company aims to become a leader in the biopharmaceutical industry, leveraging its experienced leadership and disciplined approach to product development [11]

Core Insights - Zenas BioPharma announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS), achieving a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo [1][2][3] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [12] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate [12] Clinical Trial Results - The MoonStone trial enrolled 116 patients and demonstrated a near-complete suppression of new GdE T1 hyperintense lesions by 8 weeks, sustained through week 12 [3][9] - The adjusted mean number of new GdE T1 lesions per scan in the obexelimab group was 0.01 compared to 0.23 in the placebo group [3] - Obexelimab also significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions, indicating a reduction in disease burden [3] Future Developments - Zenas plans to report 24-week data from the MoonStone trial in Q1 2026, which will include additional secondary and exploratory endpoints [4] - The company expects to report topline results from the Phase 3 INDIGO trial in IgG4-RD by the end of 2025 and from the Phase 2 SunStone trial in Systemic Lupus Erythematosus by mid-2026 [4] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depleting them, targeting both CD19 and FcγRIIb [10][12] - This unique mechanism may effectively address the pathogenic role of B cells in chronic autoimmune diseases [10][12] Disease Context - Multiple Sclerosis (MS) is a chronic autoimmune disorder affecting approximately 2.9 million people globally, with RMS being the most common subtype [5][8] - Early intervention with effective therapies is crucial to manage the disease and prevent disability progression [7][8]

Group 1 - The Zenas deal reflects a trend of U.S. pharmaceutical companies seeking innovation from China, where biotechnology startups benefit from lower costs and regulatory flexibility [3] - Concerns are rising among U.S. biotech companies and investors about losing competitive edge due to the growing pipeline of drugs from China, prompting a bipartisan commission to warn about the situation [4] - The pace of licensing Chinese drugs has accelerated, with four deals announced in the previous month, despite calls from top pharmaceutical executives for government support to bolster the U.S. biotech industry [5] Group 2 - Zenas BioPharma is enhancing its pipeline by acquiring three experimental autoimmune medicines from InnoCare Pharma, including a multiple sclerosis treatment currently in Phase 3 testing [6][7] - InnoCare is set to receive up to $100 million in upfront and near-term cash payments, with the total deal potentially exceeding $2 billion, including royalties [7] - Zenas has also secured a private placement of stock worth approximately $120 million to ensure operational cash flow into late 2026 and possibly early 2027 [7]

Investment Rating - The investment rating for InnoCare Pharma (H share) is "Buy" with a 12-month target price of HK$12.72, indicating a downside potential of 7.6% from the current price of HK$13.76 [8][9]. Core Insights - InnoCare Pharma is on track for commercial progress, with management guiding for one major business development (BD) deal in the second half of 2025 [1][2]. - The company expects peak sales of over US$1 billion for orelabrutinib in China, driven by various indications including hematologic cancers, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) [6][8]. - Upcoming data readouts over the next 12 months include phase 2b data for orelabrutinib on SLE and phase 3 data for ICP-488 on psoriasis [7]. Summary by Sections Business Development Focus - The management's priority for out-licensing will focus on immunology disease assets, particularly: 1. ICP-332, which has shown promising phase 2 data for atopic dermatitis and is also being studied for vitiligo and prurigo nodularis [2]. 2. ICP-488, with accelerated patient enrollment for phase 3 trials on psoriasis [2]. 3. Orelabrutinib, with global trials planned for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [2]. Commercialization Progress - The company reported that commercial execution in Q2 was on track, with a year-on-year growth expectation of over 35% for orelabrutinib [3]. Financial Projections - Revenue projections for InnoCare Pharma indicate growth from Rmb1,009.4 million in 2024 to Rmb2,717.9 million by 2027, with EBITDA improving from a loss of Rmb547.3 million in 2024 to a profit of Rmb194.4 million in 2027 [9].

Core Insights - InnoCare reported solid 1Q25 results with revenue reaching RMB381 million, driven by a significant increase in orelabrutinib sales, which rose 89% YoY to RMB311 million [1] - The company expects orelabrutinib sales to be primarily supported by its uptake in marginal zone lymphoma (MZL), projected to account for approximately 50% of sales by year-end 2025 [1] - Management has raised the FY25 sales growth target for orelabrutinib from 30% to over 35% [1] Financial Performance - InnoCare's net income for 1Q25 was RMB14 million, bolstered by strong orelabrutinib sales and an upfront payment of US$8.75 million from out-licensing its CD3/CD20 asset [1] - The product gross margin improved to 88.4%, up from 86.2% in FY24, indicating enhanced manufacturing efficiency [1] - The SG&A ratio declined to 50%, down from 60% in FY24, reflecting better cost discipline [1] - As of 1Q25, InnoCare maintained a robust cash position of RMB7.8 billion, providing ample capital for R&D initiatives [1] Pipeline Development - InnoCare's autoimmune pipeline is viewed as a key growth driver, with orelabrutinib showing strong potential in multiple sclerosis (MS) [1] - Two Phase 3 trials for orelabrutinib in MS are advancing in the US, targeting primary progressive MS (PPMS) and secondary progressive MS (SPMS) [1] - In the oncology sector, InnoCare is progressing with mesutoclax (ICP-248) as a competitive Bcl-2 inhibitor, with a Phase 3 trial ongoing for first-line chronic lymphocytic leukemia (CLL) [2] - Tafasitamab (CD19) is on track for approval in China for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), enhancing the hematology portfolio [2] Strategic Outlook - InnoCare is targeting less crowded indications overseas, including first-line acute myeloid leukemia (AML) and BTK inhibitor-pretreated mantle cell lymphoma (MCL) [2] - The company is advancing its in-house antibody-drug conjugate (ADC) platform, with an IND for a B7-H3-targeting ADC submitted in April 2025 [2] - The significant out-licensing potential across multiple assets, particularly orelabrutinib and ICP-332, is highlighted as a strategic advantage [3]

Core Viewpoint - InnoCare Pharma reported strong financial performance in Q1 2025, with significant revenue growth and a shift to profitability, driven by the sales ramp-up of its key product, orelabrutinib [1][5]. Financial Performance - Q1 2025 revenue reached Rmb381 million, representing a 130% year-over-year increase, while net profit was Rmb18 million, a turnaround from net losses of Rmb142 million in Q1 2024 [1]. - Sales of orelabrutinib amounted to Rmb311 million, reflecting an 89% year-over-year growth [1]. - R&D expenses were Rmb208 million, up 17% year-over-year, and selling expenses reached Rmb114 million, increasing by 27% year-over-year, with the selling expense ratio decreasing by 24.1 percentage points to 30% [1]. - Gross profit margin improved by 5.2 percentage points to 90.5% due to enhanced production efficiency and contributions from business development revenue [1]. - As of March 2025, the company had a cash balance of approximately Rmb7.8 billion [1]. Product Development and Sales Outlook - The sales target for orelabrutinib has been raised from over 30% year-over-year to over 35% year-over-year for 2025, supported by the addition of three indications into the National Reimbursement Drug List (NRDL) and recent NMPA approval for first-line CLL/SLL [1]. - Orelabrutinib is currently undergoing phase III trials for immune thrombocytopenic purpura (ITP) in China, with a new drug application (NDA) expected in the first half of 2026, and phase IIb trials for systemic lupus erythematosus (SLE) with data readouts anticipated in Q4 2025 [1]. Other Product Developments - The Biologics License Application (BLA) for tafasitamab for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) was accepted by the NMPA, with approval expected in 2025 [2]. - ICP-248 (BCL-2) is in phase III trials in combination with orelabrutinib for first-line CLL/SLL, and has received breakthrough therapy designation (BTD) from the CDE for r/r mantle cell lymphoma (MCL) [2]. - The company is actively developing pipelines for autoimmune diseases, including phase III trials for atopic dermatitis (AD) and psoriasis, and has pre-clinical assets targeting IL-17 [3]. ADC Product Development - The company filed an Investigational New Drug (IND) application for its first antibody-drug conjugate (ADC) product, ICP-B794 (B7-H3 ADC), which has shown promising therapeutic effects and safety in preclinical studies [4]. Investment Outlook - The EPS forecast has been adjusted from -Rmb0.21 to -Rmb0.19 for 2025, from -Rmb0.06 to -Rmb0.05 for 2026, and a forecast of Rmb0.16 for 2027 [5]. - The target price has been raised from HK$10.0 to HK$11.8, indicating a 25% upside potential, and the company maintains a BUY rating [5].