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Sinovent Secures USD 97.2 Million in Series E Financing to Boost Clinical Trials and Commercialization
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Sinovent Inc., a Suzhou-based biopharmaceutical company, has announced the successful completion of a Series E financing round, raising RMB 700 million (USD 97.2 million). The round was co-led by Tencent Investment and Guoxin Investment, with additional contributions from Jinan Industrial Development Investment, Huakong Investment, Yuekai Securities, Sea of Stars Capital,…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
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Beijing, Tianjin, and Hebei Release Draft Proposal for Updated Drug Clinical Trial Inspection Standards
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The medical products administration bureaus of Beijing, Tianjin, and Hebei province have released a draft proposal for the “Supervision and Inspection Standards for Clinical Trial Institutions of Drugs in the Beijing Tianjin Hebei Region (2024 Edition)” and are soliciting public feedback from February 8 to March 8, 2024. The 2024…
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AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the US Food and Drug Administration (FDA) for its lung cancer therapy Tagrisso (osimertinib). The fresh indication allows for the use of Tagrisso in combination with chemotherapy for patients with advanced or metastatic epidermal growth factor…
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Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application…
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China’s CDE Issues Guiding Principles for ADC Research and Evaluation
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China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates (ADCs).” The document aims to standardize and guide the research, development, and regulatory submissions pertaining to ADCs. The guidelines are applicable to ADC products that are created…
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GSK and Peers Respond to FTC Criticism, Withdraw Patent Listings from US Orange Book
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Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade Commission’s (FTC) allegations of “abusive” patents by withdrawing several listings from the US Orange Book. This action follows the FTC’s challenge in November against over 100 patents held by manufacturers of branded asthma inhalers, epinephrine…
