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Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
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J&J MedTech Secures Exclusive Distribution Deal with Responsive Arthroscopy
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading player in the US medical technology sector, has announced an exclusive commercial distribution agreement with Responsive Arthroscopy Inc., an innovative medical device company specializing in sports soft tissue repair solutions. This strategic partnership is aimed at bolstering J&J MedTech’s sports medicine…
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Jiangsu Hengrui Receives NMPA Approval for SHR-2173 Clinical Trial in ITP
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational biologic product, SHR-2173, in patients with primary immune thrombocytopenia (ITP). This development marks a significant step forward in expanding treatment options…
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Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients…
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BeiGene Ltd to Become BeOne Medicines Ltd, Emphasizing Global Oncology Commitment
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China-based biotechnology company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a proposed change of its English name to BeOne Medicines Ltd. This rebranding underscores the company’s dedication to developing innovative medicines aimed at eliminating cancer and its intention to partner with the global community to serve a…
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Beijing Biostar Partners with Baheal for Utidelone Market Promotion in China
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Beijing Biostar Technologies Ltd (HKG: 2563), a synthetic biology-driven anti-tumor drug specialist that made its debut in Hong Kong last month, has entered into a market promotion service agreement with Baheal Pharmaceutical Group (SHE: 301015), a leading health services and distribution company in China. This collaboration will see Baheal provide…
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Sino Biopharmaceutical’s TQB3002 Receives FDA Clearance for Phase I Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based pharmaceutical company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its TQB3002. This is an in-house developed fourth-generation epidermal growth factor receptor (EGFR) inhibitor, marking a significant…
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PegBio Files for IPO on Hong Kong Stock Exchange
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PegBio Co., Ltd., a specialist in endocrine metabolism based in Suzhou, has taken a significant step towards going public with an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKSE). While the price and other specific details of the offering are yet to be disclosed, the move…
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Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its antibody drug conjugate (ADC), 9MW2821. This drug targets Nectin-4 and will be evaluated in combination with programmed-death 1 (PD-1)…
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WuXi Biologics Expands Sterile Filling Capabilities in Germany with New Line
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China’s Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced plans to establish a new sterile filling line for prefilled syringes (PFS) at its facility in Leverkusen, Germany. This move is set to enhance the company’s drug product (DP) capabilities in the region, optimizing the facility’s…
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Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its JMX-2002 liposome injection. This innovative drug, known for its high efficiency and safety, is now set to commence clinical studies focusing on solid tumors, including non-small…
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Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
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Singapore-based clinical-stage biotechnology company Lion TCR, supported by Chinese investors, has secured tacit clinical approval from the National Medical Products Administration (NMPA) for its innovative therapy GZL-016. This approval marks a significant milestone in the development of mRNA T-cell receptor engineered T-cells (TCR-T) therapy aimed at treating hepatitis B virus-associated…
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BeiGene to Rebrand as BeOne Medicines, Emphasizing Global Commitment to Cancer Care
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading global innovator in oncology treatments, announced its intention to adopt a new English name: BeOne Medicines Ltd. The rebranding reflects the company’s mission to unite global efforts in the fight against cancer and underscores its transformative approach to fostering cross-sector…
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Eli Lilly’s Tirzepatide Shows Sustained Weight Loss in 176-Week Study
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has released 176-week follow-up data from its Phase III SURMOUNT-1 study for tirzepatide, marking the longest completed study to date for the dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This data provides significant insights into the drug’s…
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GE Healthcare’s SIGNA MAGNUS MRI Scanner Receives FDA 510(k) Clearance
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US medical device and life sciences leader GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced the receipt of FDA 510(k) clearance for its innovative SIGNA MAGNUS, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This clearance marks a significant advancement in medical imaging technology, offering new capabilities for the…
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Cullgen and Pulmatrix Merge to Form Nasdaq-Listed Protein Degradation Company
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Cullgen Inc., a clinical-stage biopharmaceutical company with operations in China, the US, and Japan, is poised to merge with US-based Pulmatrix, Inc. (NASDAQ: PULM). The merger will result in a Nasdaq-listed entity focused on advancing targeted protein degradation technology, a promising field in drug development. Cullgen’s uSMITE Technology PlatformCullgen leverages…
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ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a leading biopharmaceutical company specializing in immuno-oncology, has announced the commencement of a Phase II clinical study for its investigational drug, IMM27M, targeting estrogen receptor positive (ER+) advanced breast cancer following endocrine therapy failure or recurrence. This announcement coincides with the enrollment of…
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Huadong Medicine’s Biosimilar SaiLeXin Receives First National Prescription in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative…
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Zucara Therapeutics Secures $20M Series B Financing Led by Sanofi and PXV Fund
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Canada-based diabetes life sciences company, Zucara Therapeutics Inc., has announced the receipt of a strategic investment totaling USD 20 million from global pharmaceutical leader Sanofi (NASDAQ: SNY) and Perceptive Xontogeny Venture Fund (PXV Fund I). This investment is a significant component of Zucara’s USD 20 million Series B financing round,…
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Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
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The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
