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BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
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Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application of its drug azacitidine in Shenzhen, within the Guangdong Hong Kong Macao Greater Bay Area (GBA). This marks the use of the world’s first and only oral maintenance therapy for acute myeloid leukemia (AML) in…
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Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
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Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT…
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Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I study for its investigational biologic product BC001. The study will assess the safety, tolerability, efficacy, and pharmacokinetics of BC001, a…
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Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
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The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have…
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Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate HSK39775, intended for the treatment of advanced solid tumors. Preclinical study results have demonstrated HSK39775’s potential efficacy across…
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Harbour BioMed Partners with Boostimmune to Develop Novel ADC Therapies
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced an antibody drug conjugate (ADC) discovery cooperation agreement with South Korea-based ADC specialist Boostimmune, Inc. The financial details of the agreement have not been disclosed. As per the terms…
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BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
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BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
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Novo Nordisk Partners with Neomorph to Target Undruggable Diseases with Molecular Glue Degraders
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Danish pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has entered into a partnership with US-based Neomorph to discover, develop, and commercialize molecular glue degraders targeting specific indications in cardiometabolic and rare diseases. Neomorph will be responsible for the discovery and pre-clinical development of the candidates, for which it will receive up…
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AstraZeneca Expands Global Footprint with Shanghai Strategic Center
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AstraZeneca (AZ, NASDAQ: AZN) has declared that Shanghai is now its fifth global strategic center, joining the ranks of Cambridge in the UK, Boston and Gethersburg in the United States, and Gothenburg in Sweden. This move is complemented by AstraZeneca’s plan to collaborate with innovative pharmaceutical companies in Shanghai for…
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Kexing Pharmaceutical Partners with Yabao to Distribute Generic Nexavar in Ten Countries
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into an overseas cooperation agreement with fellow domestic firm Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) to distribute a generic version of Bayer (ETR: BAYN)’s Nexavar (sorafenib). Under this agreement, Kexing will serve as the exclusive agent for the tyrosine kinase inhibitor (TKI)…
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GenScript’s Subsidiary Legend Biotech Gets CHMP Nod for Carvykti Label Expansion in Multiple Myeloma
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the label expansion of its (BCMA)-directed chimeric antigen receptor T…
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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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Mabwell Bioscience’s Nectin-4 Targeting ADC Earns FDA Fast-Track Designation for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
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Boehringer-Ingelheim Partners with CBmed to Accelerate First-in-Class Cancer Medicines Development
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Boehringer-Ingelheim, a German pharmaceutical giant, has entered into a long-term strategic partnership with Austria-based CBmed GmbH Center for Biomarker Research in Medicine (CBmed). The collaboration aims to leverage translational medicine approaches to expedite the development of first-in-class oncology drugs, with the ultimate goal of transforming the lives of cancer patients…
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Jiangsu Hengrui Receives NMPA Approval for Adjuvant Therapy Clinical Study of Adebrelimab in NSCLC
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its PD-L1 monoclonal antibody (mAb) adebrelimab (SHR-1316) in combination with chemotherapy as adjuvant therapy for patients with resectable stage II or III…
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Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug HP537, targeting hematologic malignancies. This development marks a significant step for Hinova Pharmaceuticals as…
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Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Immune-Onc Therapeutics’ IO-202 Earns Orphan Drug Designation for CMML from US FDA
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Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate IO-202, which is being developed to treat chronic myelomonocytic leukemia (CMML). This potential first-in-class LILRB4 antagonist was…
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Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
