Stapokibart

CHENGDU, China, Aug. 20, 2026 /PRNewswire/ -- On August 19, 2026, Keymed Biosciences (HKEX: 02162) announced its interim results for the six months ended June 30, 2026. Guided by a clear dual-engine driven strategy, the company demonstrated outstanding execution capabilities: In the domestic market, following the successful commercialization and implementation of medical insurance coverage for the core product Kangyueda, the company's highly qualified in-house marketing team rapidly stepped up its efforts, driving a robust breakthrough in domestic commercialization revenue from "1 to N", and providing the Company with a robust cash flow and a solid performance foundation. In the overseas market, the research and development capabilities of Keymed continued to be recognized by multinational pharmaceutical companies. Overseas out-licensing collaborations in respect of its key pipelines and their steady clinical advancement not only validated the Company's innovative capabilities, but also generated substantial upfront payments and milestone revenue. The steady increase in domestic sales and the continued advancement of overseas (BD) activities complemented each other, establishing a dual-engine driven growth model with exceptional resilience and explosive growth potential. Rapid Growth in Sales Revenue, and Cash Flows Contribution from Business Development In the first half of 2026, the company achieved total revenue of RMB617 million, mainly boosted by the strong performance of our commercialization product, Kangyueda's revenue increased by 132% to RMB393 million. Collaboration revenue amounted to RMB224 million for the six months ended June 30, 2026, primarily attributable to the milestone payment received under the exclusive license agreement with AstraZeneca AB, attesting to the robust potential of our pipeline. Profit for the period reached RMB1,220 million. The swing from loss to profit was primarily driven by the successful merger and acquisition of our NewCo by MNC and rapid revenue growth, alongside enhancement in operational efficiency. The Company's cash reserves (including cash and cash equivalents, time deposits, and financial assets at FVTPL) amounted to approximately RMB3.24 billion, providing a solid financial foundation for its sustainable growth and global innovation. Dual-wheel Drive Fully Launched, Pipeline Portfolio Gaining Momentum In 2026, Kangyueda entered the first year of full-scale volume growth under medical insurance coverage. As of June 30, 2026, the Company's commercialisation team comprised nearly 500 personnel, covering more than 1,600 hospitals and over 260 cities, with market access initiatives progressing rapidly. Kangyueda generated sales revenue of RMB393 million, representing a year-on-year increase of 132%. In July 2026, Kangyueda was officially included in the National Essential Medicines List (2026 Edition), which took effect on September 1, 2026. Pursuant to the relevant administrative requirements for essential medicines, public medical institutions at all levels nationwide are required to procure and give priority to the use of medicines included in the list. Such inclusion is conducive to enabling Kangyueda to overcome its previous limitations in Grade III Class A hospitals, accelerating its penetration into county-level and primary healthcare markets, broadening terminal prescription settings and further enhancing the accessibility of the medicine. In January and March 2026, the marketing applications for Stapokibart for the treatment of moderate-to-severe AD in adolescents and prurigo nodularis (PN) were accepted by the NMPA. Concurrently, we are advancing a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in pediatric subjects with moderate-to-severe AD. As of the date of this announcement, patient enrollment is ongoing. In July 2026, we initiated a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection with background therapy for the treatment of adolescent patients with SAR. BD Milestone Realization Drives Further Acceleration of Global R&D CM336 (BCMA x CD3 bispecific antibody): On June 5, 2026, the Group's NewCo partner, Ouro Medicines, was successfully acquired by Gilead and Lakefront (Euronext & Nasdaq: LKFT, formerly known as Galapagos), and the transaction has been officially completed. The Group has received an upfront payment of US$257 million, and is entitled to receive milestone payments of up to approximately US$70 million. In addition, the exclusive license agreement entered into between the Group and Ouro Medicines in November 2024 remains in effect. The milestone payments of up to US$610 million will be fulfilled by Gilead and Lakefront, and the tiered royalties on net sales ranging from high single digits to mid-double digits will be fulfilled by Gilead. Through this transaction, Lakefront acquired substantially all of the team and operating assets of Ouro Medicines, and will collaborate with Gilead on the subsequent development of CM336/OM336. Lakefront will be responsible for the ongoing and future Phase I/II clinical studies of CM336/OM336, while Gilead will lead the pivotal registrational and late-stage studies. The exclusive global commercialisation rights (excluding the Greater China region) are solely owned by Gilead. CMG901/AZD0901 (Claudin 18.2 ADC): The CLDN18.2 ADC, in collaboration with AstraZeneca, is leading the global clinical development timeline among the first tier. CMG901/AZD0901 has obtained Fast Track Designation and Orphan Drug Designation from the FDA for second-line or later gastric cancer as well as Breakthrough Therapy Designation from the CDE, with OS demonstrating a statistically significant and highly clinically meaningful benefit (CLDN18.2 expression rate ≥25% for enrolled subjects). The global multi-center Phase III clinical trial for first-line gastric cancer completed its first patient enrollment in early 2026, and the perioperative gastric cancer study is in the Phase II clinical stage. The development is further differentiated by expanding into additional tumor types, including biliary tract cancer and pancreatic cancer. CM355/PRO-203 (CD20 x CD3 bispecific antibody): Prolium continues to advance an international multi-center Phase I/II clinical study of CM355/PRO-203 for SSc, and completed the dosing of the first patient with systemic sclerosis in June 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026. Intensive Pipeline Breakthroughs, Next-generation blockbuster lead a new iteration CM512 (a TSLP/IL-13 bispecific antibody): Next-generation blockbuster CM512 is poised to succeed Kangyueda and lead a new iteration of autoimmune disease treatment. As the world's first IgG-like long-acting dual TSLP/IL-13 inhibitor, CM512 has a half-life of up to 70 days, has met all clinical endpoints in the Phase II clinical trial for CRSwNP. CM512 demonstrates a rapid onset of action, capable of rapidly shrinking nasal polyps at week 4 post-dosing while significantly improving nasal congestion and promoting the recovery of olfactory function. The efficacy of a single injection can be maintained for six months. At week 24, its change from baseline in the Nasal Polyp Score (NPS) was significantly superior to that of the control group, while overall inflammation of the sinus cavity was significantly reduced, and its Phase III clinical trial has been rapidly initiated. The Company has also established a presence in indications including moderate-to-severe asthma, moderate-to-severe COPD, moderate-to-severe AD in adults, perennial allergic rhinitis, and chronic spontaneous urticaria. CM336 (BCMA x CD3 bispecific antibody): In the field of autoimmune diseases, we continued to advance an open-label, multi-center Phase II clinical study to evaluate the efficacy and safety of CM336 injection for the treatment of relapsed or refractory primary light-chain amyloidosis in the first half of 2026, and this study is currently in the patient enrollment phase. In May 2026, CM336, intended for the treatment of relapsed or refractory light-chain amyloidosis in patients previously treated with bortezomib and CD38 monoclonal antibody (mAb), was included in the Breakthrough Therapy Designation list. In the first half of 2026, we continued to advance a Phase I/II clinical study to evaluate the safety and efficacy of CM336 injection for the treatment of subjects with relapsed or refractory autoimmune cytopenias. As of the date of this announcement, patient enrollment for Phase I of the clinical study has been completed. In July 2026, an open-label Phase Ib study was initiated to evaluate CM336 injection in patients with active Sjögren's syndrome. In the field of oncology, the IND application for the Phase III clinical trial of CM336 in combination with CM313 (a CD38 mAb) for second-line or later-line RRMM was accepted by the National Medical Products Administration (the "NMPA") on July 3, 2026. The study is divided into two parts: Part 1 is a non-randomized safety run-in phase, and Part 2 is a randomized controlled registration cohort, which will evaluate multiple dosing regimens compared to SOC. The trial will be initiated upon receipt of the clinical trial approval. Other Pipeline Programs Progressing Steadily: CM313: Continued to advance a randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313 (SC) injection in subjects with IgA nephropathy. As of the date of this announcement, this study is in the patient enrollment phase. CM518D1: Continued to advance a multi-center, open-label Phase I/II clinical trial. To date, the Company has submitted Investigational New Drug (IND) applications for multiple pipeline candidates, including CM529D1 (a DLL3/SEZ6 bispecific ADC) for small cell lung cancer, CM583 (a long-acting CGRP/PACAP bispecific antibody) for migraine, and CM551 (a long-acting TL1A/IL-23 p19 bispecific antibody) for inflammatory bowel disease. We expect that multiple First-in-Class pipeline candidates will enter the IND and clinical stages, including long-acting bispecific antibodies, bispecific ADCs, siRNA and Protac, to address global unmet medical needs in chronic diseases and oncology. Sustained Momentum in R&D, Production, and Talent Solidifies the Foundation We have built 6 fully-integrated platforms to enable our in-depth R&D in the areas of immunology and oncology including: Antibody Discovery Platform, KeyMedSTAR™ ADC Platform, TCE Bispecific Antibody Platform, VESIR™ Oligonucleotide Platform, Small Molecule Platform and KeyCND™ Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Our platforms are integrated seamlessly to support key drug development functionalities, including antibody screening, small molecule lead compound discovery, antibody conjugation, functional evaluation, in vivo preclinical studies and biomarker identification. We have the expertise and capability to independently complete the entire drug development process from drug discovery to preclinical research to clinical development and to NDA/BLA application. To ensure production and supply of high-quality and affordable antibody drugs, we have always been committed to enhancing our in-house manufacturing capabilities. We have internally developed high-expressing cell lines to ensure high yield and low costs for our antibody drugs manufacturing. As of the date of this announcement, the production base in Chengdu has 3 pilot production lines and 3 commercial production lines, with a total production capacity of 21,800 litres. The stainless steel production lines with an additional production capacity of 24,000 litres have completed installation and commissioning and will soon be put into use. All such designs comply with the cGMP requirements of the NMPA and the FDA. As of June 30, 2026, we had 1,768 full-time employees in total, including nearly 500 employees engaging in commercialization and nearly 420 employees engaged in drug discovery and clinical operations. We will continue to recruit talent to meet the growing needs of commercial sales of products, research and development, clinical, production and the Company's operations. Standing at the brand-new starting point of its tenth anniversary, Keymed will continue to uphold its "patient-centric" original aspiration. Leveraging the robust momentum of its dual-drive strategy, the Company will accelerate the research and development and commercialisation process of its global pipeline, committing to providing more high-quality and accessible innovative therapies for patients worldwide, and creating long-term, sustainable, and exceptional value for Shareholders. SOURCE Keymed Biosciences 21% more press release views with Request a Demo