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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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BeyondSpring Presents Positive Phase II Data for Plinabulin Combination Therapy in NSCLC at SITC
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BeyondSpring Inc. (NASDAQ: BYSI), a US-based biotech company, has announced the presentation of the latest results from the Phase II KeyPelms-004 study at the 39th Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The study evaluated the efficacy and safety of plinabulin combined with pembrolizumab plus docetaxel in patients with…
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Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Mabwell Bioscience Cancels Licensing Agreements with Yangtze River Pharma for Two Drug Candidates
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced the cancellation of licensing agreements with Yangtze River Pharmaceutical Group for two of its drug candidates: 8MW0511, a recombinant (yeast secreted) human serum albumin human granulocyte colony-stimulating factor (I) fusion protein for injection, and 9MW1111,…
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3D Medicines Partners with Sino Cellbiomed to Advance Tumor Immunotherapy Development
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3D Medicines (HKG: 1244), a China-based oncology specialist, has entered into a partnership with Sino Cellbiomed, a Qingdao-based cell therapy firm, to collaborate on the development of tumor immunotherapies. Financial terms of the agreement have not been disclosed. Since its debut on the Hong Kong Stock Exchange in December 2022,…
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Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
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Jiangsu Hengrui Medicine Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study. The study will assess the efficacy of three of the company’s novel pipeline candidates in combination regimens against general solid tumors. The drugs in…
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Innovent Biologics Expands Partnership with Synaffix for New ADC Development
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Innovent Biologics Inc. (HKG: 1801) has announced an expanded partnership with U.S.-based Synaffix B.V., a subsidiary of Lonza (SWX: LONN). This follows an initial agreement from June 2021, during which Innovent successfully utilized Synaffix’s antibody-drug conjugate (ADC) technology platforms on a non-exclusive basis to develop IBI343, an anti-CLDN18.2 ADC that…
