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China-based HitGen Inc. (SHA: 688222) has announced a research agreement with ARase Therapeutics, Inc. Under this collaboration, HitGen will leverage its DNA-encoded library (DEL) technology platform, which specializes in the design, synthesis, and screening of DELs, to identify novel inhibitors of ARase’s validated oncology targets. HitGen will also provide support…
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China-based biotech BeiGene (NASDAQ: BGNE) has formed a collaboration with US-based non-profit organization The Max Foundation (Max) to improve access to the Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for patients with chronic lymphocytic leukemia (CLL) in 29 low- and middle-income countries. The three-year collaboration aims to enhance access to…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its small molecule drug HDM1002, intended for the treatment of adult type 2 diabetes. This follows closely on the heels of the drug’s approval to enter clinical trials in…
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Everest Medicines (HKG: 1952), a China-based biopharmaceutical company, has declared the successful completion of patient enrollment in a multi-center Phase III clinical trial for etrasimod in Asia, specifically targeting the treatment of moderate-severe active ulcerative colitis (UC). This development follows Everest’s acquisition of development rights to etrasimod in Greater China…
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HuidaGene Therapeutics, a China-based biotechnology company, has announced the receipt of patent protection from the US Patent and Trademark Office (USPTO) for its cutting-edge DNA editing system, Cas12Max (CRISPR-Cas12i). This system is recognized for its superior DNA editing efficiency in mammalian cells compared to other competing systems, such as Streptococcus…
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced the receipt of another clinical trial approval for its drug candidate SHR0302, which is intended for the treatment of graft versus host disease (GVHD). SHR0302: A Selective JAK1 Inhibitor with Oral Solution PotentialSHR0302 is recognized as a highly…
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine, VaxigripTetra, has been granted market approval by the National Medical Products Administration (NMPA) in China. This approval extends the vaccine’s usage to include individuals aged three years and above, building on the earlier approval for…
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The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN) Beyfortus (nirsevimab) is on course to be awarded priority review status for its use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter…
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Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Background on Xpovio and Its ApprovalsDiscovered…
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Shanghai-based TYK Medicines has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its small molecule drug candidate, TY-2699a. This oral, selective CDK7 inhibitor is under development for the treatment of various cancers, including breast, ovarian, prostate, pancreatic, and small…
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has announced encouraging Phase I clinical study results for TST002, a drug designed to address decreased bone density in Chinese patients. Phase I Study Design and FindingsThe randomized, double-blind, placebo-controlled, dosage escalation Phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity…
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by…
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Hangzhou-based cell therapy specialist Yizun Biomedicine Co., Ltd has announced the completion of first patient enrollment and reinfusion in an investigator-initiated trial (ITT) for its CNK-UT cell therapy, targeting advanced solid tumors at Shulan Hangzhou Hospital. CNK-UT Cell Therapy: A Universal Cell Technology for Tumor TreatmentCNK-UT is a groundbreaking universal…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that the results of three clinical studies for its Category 1 drug jacktinib in myelofibrosis have been shortlisted for the European Hematology Association (EHA) annual meeting this year. Phase III Study: Jacktinib vs. Hydroxyurea in MyelofibrosisA randomized, double-blind Phase III study…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate ZG0895, which targets advanced solid tumors. ZG0895 is a highly selective toll-like receptor (TLR8) agonist developed in-house, designed to offer a new…
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Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDC) headquartered in Suzhou, has declared the successful completion of Series B and Series B+ financing rounds, totaling $100 million. The initial Series B round was led by HM with support from Yuanfeng Capital, V Capital, 6 Dimensions Capital, Agricultural Bank…
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The US Securities and Exchange Commission (SEC) has announced that Dutch device company Philips (BVMF: PHGN34) has agreed to a $62 million resolution to settle charges related to improper employee practices during the marketing of products in China between 2014 and 2019. In the settlement, which Philips accepted without admitting…
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Peijia Medical Limited (HKG: 9996), a leading China-based medical device company, has announced the successful completion of the first two commercial implants using its transcatheter aortic valve replacement (TAVR) product, the Trilogy heart valve system, in Hong Kong. This marks a significant milestone as the Trilogy system is the first…
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US-based biotech company BiOneCure Therapeutics Inc. has entered into a strategic collaboration with China-based Nanjing Leads Biolabs. The partnership aims to develop a range of innovative antibody drug conjugates (ADCs) that target solid tumors, marking a significant step in the advancement of cancer treatments. Combining Expertise to Target Solid TumorsBiOneCure…