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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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Exegenesis Bio’s Gene Therapy EXG110 Earns Orphan Drug Status for Fabry Disease
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Exegenesis Bio, a leading provider of epigenetics experimental and analytical services headquartered in Hangzhou, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary gene therapy, EXG110, which is indicated for the treatment of Fabry disease. This designation highlights…
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Shenzhen Weiguang Biological Partners with SUAT to Boost Life Science and Health Industry
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Shenzhen Weiguang Biological Products Co., Ltd. (SHE: 002880), a prominent blood products manufacturer in China, has entered into a strategic partnership with Shenzhen University of Advanced Technology (SUAT). This collaboration, focused on the life and health sector, aims to foster the integration of industry and education, enhance cooperation among industry,…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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C-Ray Therapeutics Secures Over $100 Million in Series A+ Financing for Radiopharmaceuticals
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C-Ray Therapeutics, a specialist in radiopharmaceuticals headquartered in Chengdu, has announced the successful completion of a Series A+ financing round, raising over USD 100 million. The funding was co-led by Shenzhen Capital Group’s Manufacturing Transformation and Upgrading New Materials Fund and Tailong Capital, with additional contributions from GL Ventures, 3SBio…
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BioNTech Acquires Biotheus for $800 Million, Enhancing Oncology Pipeline
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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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Suzhou Ribo Life Science Receives EU Approval for Phase II Trial of RBD5044
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Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB have announced that their novel siRNA drug, RBD5044, has received approval to commence Phase II clinical trials in the European Union. This represents a significant step forward in the development of RNA interference therapies targeting lipid metabolism. RBD5044:…
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Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
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C-Ray Therapeutics Secures Over $100 Million in A+ Round Financing
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C-Ray Therapeutics (Chengdu) Co., Ltd., an innovative enterprise in the field of radioactive medicines, has successfully completed over $100 million in A+ round financing. This funding round was jointly led by Shenzhen Capital Group’s New Materials Fund and Tailong Investment, with participation from notable investors including Hillhouse Ventures, SiBiono GeneTech,…
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Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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Merck KGaA Reports 3.8% Organic Growth in Q3 2024 Financials
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Merck KGaA (NYSE: MRK), the German multinational science and technology company, has released its financial results for the third quarter of 2024, reporting net sales of EUR 5.266 billion (USD 5.55 billion), marking an organic growth of 3.8%. The company’s performance reflects a steady increase in sales across its business…
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Impact Therapeutics Secures $34.5 Million in Series D++ Financing for Senaparib Commercialization
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China-based biopharmaceutical company Impact Therapeutics has reportedly secured RMB 250 million (USD 34.5 million) in a Series D++ financing round, co-led by a globally renowned industry investment institution and a prominent insurance fund. The funds raised will be directed towards the commercialization of its core product, senaparib, a PARP1 inhibitor,…
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GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
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Janssen-Cilag’s Nipocalimab Shows Promise in Phase II Study for Sjögren’s Disease
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Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
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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…
