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Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC)…
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Global healthcare leader Merck, Sharp & Dohme (MSD) (NYSE: MRK) has secured a strategic acquisition of Abceutics, a preclinical biopharmaceutical startup focused on optimizing antibody-drug conjugates (ADCs). The financial details of the transaction remain undisclosed. Abceutics has developed a series of payload-binding selectivity enhancers (PBSEs) designed to increase the safety…
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Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
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Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
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Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment…
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ)…
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Adicon Holdings Ltd (HKG: 9860), a China-based independent clinic laboratory service provider, has announced the launch of its GuardantOMNI test, a 500-gene panel based on blood sample detection, alongside its previously introduced liquid biopsy product, Guardant360. This initiative aims to enhance the development of tumor-targeted drugs and immunotherapies in clinical…
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German pharmaceutical giant Merck (ETR: MRK) has entered into a strategic collaboration with Caris Life Sciences’ research unit, Caris Discovery, to uncover novel oncology targets and develop first-in-class antibody-drug conjugates (ADCs). The partnership aims to harness Caris’ precision medicine expertise and Merck’s ADC technology to accelerate the discovery and development…
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
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Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a strategic partnership with Germany’s Boehringer Ingelheim (BI) to introduce BI’s innovative cancer therapies to the mainland China market. Under the terms of the agreement, Sino Bio will provide support for the co-development and co-commercialization of several clinical-stage drugs, including brigimadlin, zongertinib, and…