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Insilico Medicine’s AI-Discovered Drug INS018_055 Reaches Phase II Clinical Trial Milestone
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China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has announced that its lead pipeline candidate, INS018_055, has completed first dosing in patients in a Phase II clinical trial. This small-molecule, oral anti-fibrotic drug, entirely generated by Insilico’s AI platforms, is hailed as the world’s first AI-discovered molecule to reach the…
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Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
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Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar candidate BAT2206 from China’s Bio-Thera Solutions (SHA: 688177). This biosimilar candidate references Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary Janssen’s immunosuppressant Stelara (ustekinumab). The agreement builds upon a previous licensing and supply deal from 2020…
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CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings
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The Center for Drug Evaluation (CDE) has released a notice outlining the guidelines for “New Drug Benefit-Risk Assessment” within market approval filings. These guidelines, effective immediately from the publication date, are designed to standardize the process of evaluating whether the benefits of a drug outweigh its risks for a proposed…
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CNIPA Launches Pilot for Priority Patent Review for Macau Applicants in Mainland China
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The China National Intellectual Property Administration (CNIPA) has announced the commencement of a pilot program aimed at facilitating priority review over patent filings by applicants from Macau in the China mainland. This initiative is set to begin from July 1, 2023, and will allow permanent residents, companies, and other legal…
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AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China…
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Lion TCR Secures RMB 300 Million in Series B2 Financing to Advance Clinical Studies and Facility Construction
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Singapore-based clinical-stage biotechnology company Lion TCR has announced the successful completion of its Series B2 financing round, raising RMB 300 million (USD 42 million). The investment was led by Guangzhou Industrial Investment and Capital, Guoju Venture Capital, and CSPC Pharmaceutical Group. The funds will be allocated towards advancing clinical studies,…
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LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
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The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm LianBio (Nasdaq: LIAN) has been awarded priority review status for its drug mavacamten. This status is for the treatment of adult patients with symptomatic New York Heart Association (NYHA) heart function II-III obstructive hypertrophic cardiomyopathy…
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CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its in-house developed Category 1 antibody, JMT203. This marks a significant step forward in the development of this novel treatment for cancer cachexia.…
