Stapokibart

China Medical System Holdings (CMS) has submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for Comekibart (MG-K10), a long-acting anti-IL-4Rα humanized monoclonal antibody, seeking approval for the treatment of adult patients with moderate-to-severe seasonal allergic rhinitis (SAR) whose symptoms remain inadequately controlled following intranasal corticosteroid therapy. The NMPA accepted the application on 23 April 2026, marking the second NDA acceptance for MG-K10 in China, following an earlier filing for atopic dermatitis accepted in October 2025. The filing targets a specific and difficult-to-treat patient segment: adults with moderate-to-severe SAR who have already failed standard-of-care intranasal corticosteroids. MG-K10 is administered by injection on a once-every-four-weeks schedule, a dosing interval that distinguishes it from the only currently approved biologic in this class, dupilumab (Dupixent, Regeneron/Sanofi), which requires administration every two weeks. No PDUFA-equivalent review timeline has been disclosed by CMS under NMPA procedures. The clinical evidence supporting the submission comes from a multicenter, randomized, double-blind, placebo-controlled Phase III trial in adults with moderate-to-severe SAR. CMS reported that the study met its primary endpoint with statistical significance, demonstrating efficacy over placebo, alongside what the company described as a favorable safety profile. Detailed endpoint data, including the magnitude of symptom score changes and adverse event rates, have not been publicly disclosed in the filing announcement. The submission enters a nascent but no longer uncontested biologic landscape for SAR in China. Stapokibart (CM310), another anti-IL-4Rα monoclonal antibody developed by Keymed Biosciences, received NMPA approval for seasonal allergic rhinitis in February 2025, becoming the first biologic globally approved specifically for this indication. MG-K10, if approved, would join a field currently defined by a single approved agent sharing its mechanistic class. Both MG-K10 and stapokibart target the IL-4 receptor alpha subunit, blocking the downstream signaling of IL-4 and IL-13, the central cytokines driving type 2 airway inflammation. The scientific rationale for this approach in SAR mirrors the pathway validation already established across atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. What distinguishes MG-K10 within this class is its Fc-engineered extended half-life, which CMS states enables the Q4W dosing interval. Whether this translates into measurable differences in adherence or clinical outcomes relative to Q2W comparators remains to be demonstrated in head-to-head data, none of which have been disclosed. CMS obtained co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for MG-K10 in mainland China, Hong Kong, Macao, Taiwan, and Singapore through a collaboration agreement signed with Hunan Mabgeek Biotech in January 2025. Dermatological indications, including atopic dermatitis, are handled separately through CMS’s subsidiary Dermavon Holdings. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

BEIJING, March 26, 2026 /PRNewswire/ -- Keymed Biosciences (HKEX: 02162) announced its 2025 annual results. The year marked the company's 10th anniversary and a pivotal year in its transition from R&D to commercialization. Revenue Leaps Forward, Supporting Long-Term Stable Growth Since its founding in 2016, Keymed has built a pipeline of over 50 programs, with more than 10 in clinical development, three indications successfully launched, six core technology platforms continuously upgraded, over 10 external partnerships established, and planned production capacity exceeding 100,000 liters. In terms of financial performance, the company achieved a significant revenue increase. Total revenue in 2025 was approximately RMB 720 million, a 67% year-on-year increase. This included around RMB 310 million from sales of the core product Kangyueda® and approximately RMB 410 million from collaboration income. The company maintained steady R&D investment, with R&D expenses of approximately RMB 720 million. As of December 31, 2025, cash reserves stood at approximately RMB 1.96 billion, providing ample funding to support core pipeline development and long-term business growth. Core Product Commercialization in Full Swing, Continuous Expansion of Indication Footprint As of the date of this announcement, the new drug applications of Kangyueda® for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR) have been approved by the National Medical Products Administration (NMPA). Since January 2026, all launched indications of Kangyueda® and both of its packaging forms (vials and pre-filled auto-injector pens) have been included in the National Reimbursement Drug List of China, significantly enhancing affordability and accessibility for Chinese patients. During the Reporting Period, revenue for sales of Kangyueda® amounted to approximately RMB310 million. In January 2026, the new drug applications for Stapokibart for the treatment of adolescents with moderate-to-severe AD were accepted by the NMPA. Simultaneously, we are advancing a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in child subjects with moderate-to-severe AD, and as of the date of this announcement, patient enrollment is in progress. Additionally, in 2025, we continuously proceeded with a Phase III clinical study of Stapokibart injection in patients with prurigo nodularis (PN). This clinical study has completed the patient enrollment in April 2025. Global Partnerships Accelerate, Milestone Payments Validate Pipeline Value In 2025, the company advanced several core pipeline programs through out-licensing deals, accelerating clinical development and unlocking overseas value for early-stage assets at an accelerated pace. Multiple business development achievements continued to validate the company's platform innovation potential and diverse partnership model, providing sustained momentum for subsequent in-house R&D and pipeline advancement. CMG901 (AZD0901, Claudin 18.2 ADC), a first-in-class Claudin 18.2 ADC globally, has received Fast Track and Orphan Drug Designations from the FDA, as well as Breakthrough Therapy Designation from the CDE. Following its out-licensing to AstraZeneca for global development, multiple global Phase III clinical trials are being rapidly advanced. In February 2026, the first subject was dosed in this clinical trial, triggering a milestone payment subject to the terms and conditions of the license agreement. In early March 2026, KYM Biosciences Inc. (a 70% non-wholly-owned subsidiary of the Group) received the relevant milestone payment totaling US$45 million. CM336 (BCMA x CD3 bispecific antibody) was out-licensed to Ouro Medicines for global development (excluding Greater China). Open-label, multi-country basket studies are underway in the United States and Australia for relapsed/refractory autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), and other autoimmune cytopenias, with the first cohort of patients having completed dosing. Basket studies have also been initiated for active, autoantibody-positive Sjögren's syndrome and idiopathic inflammatory myopathy. In January 2026, CM336 was granted Fast Track Designation (FTD) by the FDA for the treatment of AIHA and ITP. In March 2026, Ouro Medicines announced that Gilead Sciences would acquire Ouro Medicines through a merger. The Merger Agreement provides for an upfront payment at Closing of US$1,675 million, subject to customary adjustments, and contingent milestone payment of up to US$500 million, for a maximum total of US$2,175 million. It is expected that based on the Company's equity interest in Ouro Medicines, the Group will receive an initial payment of approximately US$ 250 million, and contingent milestone payment of up to approximately US$ 70 million, for a maximum total of approximately US$320 million. The final consideration receivable by the Group is subject to the achievement of relevant milestones as well as the shareholders agreement amongst the Ouro Medicines shareholders. CM355 (CD20 x CD3 bispecific antibody) : In January 2025, the company entered into a license agreement with Prolium, granting exclusive rights for global development in non-oncology indications and for oncology indications outside Asia. Keymed and its partner InnoCare received a combined upfront and near-term payment of $17.5 million, and are eligible for milestone payments and tiered royalties totaling up to $502.5 million, as well as a minority equity interest in Prolium. As of the date of this announcement, Prolium announced the initiation of dosing in healthy subjects in a single dose-escalation study of CM355/PRO-203, and expects to initiate an international multi-center Phase I/II clinical study for the treatment of systemic sclerosis (SSc) in the second quarter of 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026. Additionally, in an investigator-initiated exploratory study, 5 patients with refractory advanced systemic lupus erythematosus (SLE) (all accompanied by lupus nephritis) are undergoing treatment evaluation. CM313 (CD38 antibody) : In January 2025, the company entered into an exclusive license agreement with Timberlyne Therapeutics for global development (excluding Greater China), receiving $30 million in upfront and near-term payments, and became the largest shareholder of Timberlyne. Promising Pipeline Data Highlights Best-in-Class Potential CM512 (TSLP x IL-13 bispecific antibody) : The Phase I study has met all study endpoints. Data showed a half-life of up to 70 days, supporting the potential for extended dosing intervals. Notably, 50% of patients in the 300 mg group achieved EASI-75 at Week 6 post-first dose, compared to 7% in the placebo group. At Week 12, EASI-75 and EASI-90 response rates in the 300 mg dose group reached 58.3% and 41.7%, respectively, versus 21.4% and 0% in the placebo group. At Week 24, response rates remained stable across all endpoints and were significantly superior to placebo. Multiple Phase II studies for CM512 have been initiated across indications including chronic rhinosinusitis with nasal polyps (CRSwNP), moderate-to-severe atopic dermatitis (AD) in adults, moderate-to-severe asthma, moderate-to-severe chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU). Notably, the Phase II study in CRSwNP has completed enrollment of 120 target patients. CM336 (BCMA x CD3 bispecific antibody) : Data from the Phase II dose-expansion cohort in relapsed/refractory multiple myeloma (RRMM) showed an objective response rate (ORR) of 95.2% in the target dose group, with a ≥ complete response (≥CR) rate of 76.2%, a minimal residual disease (MRD) negativity rate of 100%, and a 12-month progression-free survival (PFS) rate of 95.2%. The Phase III study was initiated in the second half of 2025. In 2025, we continuously proceeded with a Phase I/II clinical study to assess CM336 injection for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). As of July 2025, in the Phase II dose-expansion stage, only 4.7% of subjects experienced Grade 2 cytokine release syndrome (CRS) events, with no immune effector cell-associated neurotoxicity syndrome (ICANS) events occurring. The objective response rate (ORR) in the target dose group was 95.2%, the rate of complete response (CR) or better was 76.2%, the minimal residual disease (MRD) negativity rate was 100%, and the 12-month progression-free survival rate was 95.2%. Concurrently, in the second half of 2025, we initiated a Phase III clinical study to evaluate CM336 monotherapy versus investigator's choice (standard of care, SOC) in RRMM patients who previously have received at least second-line treatment. Other Pipeline Programs Progressing Steadily: CM518D1 (CDH17 ADC) : Initiated a Phase I/II clinical trial for advanced solid tumors. CM383 (Aβ protofibril antibody) : Completed patient enrollment in a Phase Ib study for Alzheimer's disease. CM559 (N3pG Aβ antibody): A Phase I clinical study in healthy male subjects for the treatment of early Alzheimer's disease was initiated in 2025, with the first subject enrolled in September. CM326 (TSLP antibody) : Led by CSPC Pharmaceutical Group, clinical studies for multiple indications are underway. A Phase III clinical study for moderate-to-severe asthma completed enrollment of the first subject in March 2026, and a Phase III clinical study for CRSwNP was initiated in February 2026. CM350 (GPC3 x CD3 bispecific antibody) : Phase I/II study in advanced solid tumors is in dose-escalation phase. CM369/ICP-B05 (CCR8 antibody) : Phase I dose-escalation trials continue in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Innovative Technology Platforms Continue to Evolve, Forward-Looking Positioning in Chronic Disease The company has established a diverse set of technology platforms, including Antibodies Discovery Platform, KeyMedSTAR™ (Keymed Superior Topo1i ADC Reagents) ADC Platform, TCE Bispecific Antibodies Platform, VESIR™ (VEhicle for siRNA Delivery) Oligonucleotide Platform, Small Molecule Platform and KeyCND™ (Keymed Central Nervous System Delivery) – Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Leveraging iterative and synergistic platform innovation capabilities, the company continues to efficiently generate high-quality, high-potential innovative medicines, pioneering a blue ocean in the broader chronic disease treatment landscape. Talent and Organization Continuously Optimized, High-Standard Capacity Development Accelerates As of December 31, 2025, the company had 1,625 full-time employees, including a commercialization team of over 400 and a drug discovery and clinical operations team of over 430, providing strong talent support for product commercialization and R&D. The Chengdu manufacturing facility currently has three pilot production lines and three commercial production lines, achieving a total capacity of 21,800 liters. A newly added 24,000-liter stainless steel production line has completed installation and commissioning and is about to come into operation. All facilities are designed in compliance with NMPA and FDA cGMP standards, with total planned capacity exceeding 100,000 liters in the future. The 2025 annual results comprehensively demonstrate the company's transformative progress in proprietary R&D, clinical advancement, and commercial operations, as well as its broad prospects across diversified technology platforms, innovative partnership-driven global expansion, and value realization on the world stage, underscoring the sustained and steady momentum fueled by original innovation. Keymed will continue to uphold its "patient-centric" philosophy, address unmet clinical needs, and remain committed to proprietary R&D and differentiated innovation, delivering high-quality, affordable innovative therapies to patients, while creating sustainable, long-term value for shareholders, partners, and society. SOURCE Keymed 21% more press release views with Request a Demo