-
NewCo Model: China’s Innovative Drug Companies’ New Transaction Mode in Capital Winter
•
NewCo is a new transaction model developed by Chinese innovative drug companies in response to capital winter and internationalization needs. It involves licensing overseas rights of early-stage R&D pipelines to newly established independent companies, bringing in overseas capital and management teams to accelerate development and share risks. This model combines…
-
Keymed Biosciences’ Kangyueda Gains NMPA Approval for Seasonal Allergic Rhinitis
•
China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Kangyueda (stapokibart), an anti-IL-4Rα monoclonal antibody (mAb), this time for its use in seasonal allergic rhinitis. Stapokibart previously gained NMPA approval for the treatment of severe atopic…
-
Keymed and InnoCare Announce Licensing Deal for CD20xCD3 Bispecific Antibody with Prolium
•
China-based Keymed Biosciences Inc. (HKG: 2162) and InnoCare Pharma (HKG: 9969, SHA: 688428) have jointly announced a licensing agreement with Prolium, a US-based biotech backed by RTW Investments. Under the terms of the agreement, Prolium will obtain development, regulatory filing, manufacturing, and commercialization rights to ICP-B02 (CM355), a CD20xCD3 bispecific…
-
Keymed Biosciences Licenses CM313 to Timberlyne Therapeutics for Global Development
•
China-based Keymed Biosciences Inc. (HKG: 2162) has entered into a licensing agreement with US firm Timberlyne Therapeutics, Inc., granting the startup biopharma exclusive development, manufacturing, and commercialization rights to its CM313, a CD38-targeted monoclonal antibody (mAb). The agreement covers global rights, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial…
-
Keymed Biosciences’ Kangyueda Approved for CRSwNP Treatment in China
•
China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis…
-
Keymed Biosciences Presents CM336 Data for Relapsed Multiple Myeloma at ASH Annual Meeting
•
China-based Keymed Biosciences Inc., (HKG: 2162) has announced the presentation of the latest data from the Phase I/II study for its bispecific antibody (BsAb) CM336, used for treating relapsed or refractory multiple myeloma (R/R M/M), at the 66th American Society of Hematology (ASH) Annual Meeting. Phase I/II Study Design and…
-
Jiangsu Hengrui Medicine’s SHR-1819 Receives NMPA Approval for Atopic Dermatitis Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17…
-
Keymed Biosciences Enters Global Licensing Agreement with Platina Medicines for CM336
•
Keymed Biosciences Inc., a China-based biopharmaceutical company (HKG: 2162), has announced a significant licensing agreement with UK-based Platina Medicines Ltd (PML). The agreement grants Platina Medicines exclusive global development, manufacturing, and commercialization rights to Keymed’s CM336, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial Terms and ConsiderationsUnder the terms…
-
Keymed Biosciences’ Stapokibart Receives First Prescription in China for IL-4Rα Targeting Therapy
•
China-based biotech company Keymed Biosciences Inc. (HKG: 2162) has reached a significant milestone with its drug candidate stapokibart, as it receives its first prescription in the country. This marks a pivotal step for the IL-4Rα monoclonal antibody (mAb), which is the first drug developed by a Chinese biotech to target…
-
Keymed Biosciences’ IL-4Rα mAb Stapokibart Receives NMPA Approval for Atopic Dermatitis Treatment
•
Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
-
Keymed Biosciences Strikes Licensing Deal with Belenos Biosciences for Global BsAb Rights
•
Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has entered into a licensing agreement with U.S. firm Belenos Biosciences Inc. Under the agreement, Belenos gains exclusive global rights to develop, manufacture, and commercialize Keymed’s in-house developed bispecific antibodies (BsAbs), CM512 and CM536, excluding Greater China. Belenos will…
-
Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
•
Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
-
Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb)…
-
China’s CDE Gives Tacit Approval to Keymed Biosciences’ Alzheimer’s Drug CM383 for Clinical Trials
•
The Center for Drug Evaluation (CDE) has indicated on its website that China-based Keymed Biosciences Inc. (2162.HK) has received tacit approval for its pipeline candidate drug CM383 to proceed to clinical studies. The monoclonal antibody (mAb) is intended for the treatment of Alzheimer’s disease (AD). CM383 targets amyloid-beta (Aβ), a…
-
Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
•
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR). The market filing is supported by a Phase…
-
Keymed Biosciences’ Stapokibart Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Study
•
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), has successfully achieved its primary endpoint in a Phase III clinical trial for seasonal allergic rhinitis (SAR). The Phase III study, which was multi-center, randomized, double-blinded, and placebo-parallel-controlled, aimed to…
-
Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
-
Keymed Biosciences’ Stapokibart Filing Accepted for Priority Review in China for Atopic Dermatitis
•
Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a monoclonal antibody targeting the IL-4 receptor alpha (IL-4Rα), has been accepted for priority review by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD). The filing is supported…
-
InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
•
InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
-
Keymed Biosciences’ CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma
•
China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use…
