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Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the initiation and first patient dosing of the global Phase III LOTIS-5 trial for Zynlonta (loncastuximab tesirine), an anti-CD19 antibody-drug conjugate (ADC). The study will evaluate Zynlonta in combination with rituximab as…
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that the first patient has been dosed in a Phase I clinical study of BAT8006, an in-house developed antibody drug conjugate (ADC) targeting folate receptor alpha (FRα), for advanced solid tumors. The multi-center, open-label trial will assess the drug’s safety, tolerability, and preliminary efficacy.…
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Taiwan-based OBI Pharma (TPEx: 4174) announced the discontinuation of a Phase I/II trial for its Globo H antibody OBI 888, citing manufacturing cost challenges. The decision comes despite preliminary data showing the antibody was safe, well-tolerated, and demonstrated efficacy. Reasons for HaltThe trial was stopped because OBI 888 required a…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its market filing for SHR8554, an injectable drug candidate for moderate to severe postoperative pain, has been accepted by the National Medical Products Administration (NMPA). The drug, a small-molecule μ-opioid receptor (MOR) agonist, met superiority standards in a Phase III…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an anti-RANKL monoclonal antibody (mAb) developed by subsidiary Shanghai JMT Biotechnology Co., Ltd, has been prioritized for review by the Center for Drug Evaluation (CDE). The drug is designed to address deficiencies in existing RANKL antibodies,…
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that its Category 1 therapeutic biologic product GZR4 has received clinical trial approval for treating diabetes. GZR4 is an ultra-long-acting insulin designed for once-weekly subcutaneous injection, addressing the need for more stable and convenient diabetes management. Product ProfileCurrent long-acting basal insulin analogs…
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China’s VivaVision Biotech Inc. announced the first patient enrollment in a Phase II clinical study of its dual-targeting drug VVN539 for open-angle glaucoma in the US. The trial marks progress in the company’s pipeline targeting ophthalmic disorders. Study DetailsThe randomized, double-blind, vehicle-controlled Phase II study will assess VVN539’s safety and…
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China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth Biological Technology Co., Ltd’s NR082 for the treatment of Leber hereditary optic neuropathy (LHON) caused by the G11778A mutation. The drug, an innovative intraocular injection gene therapy, uses a recombinant adeno-associated virus serotype 2 vector…
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China-based Biotheus Inc. announced that its clinical trial filing for PM1009, a bispecific antibody (BsAb) targeting T cell immunoglobulin and ITIM domains (TIGIT) and poliovirus receptor related immunoglobulin domain (PVRIG), has been accepted by the Center for Drug Evaluation (CDE). The drug, co-developed with US firm Adimab, is aimed at…
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China-based Innovent Biologics Inc. (HKG: 1801) announced that the first prescription has been filled in China for Pemazyre (pemigatinib), the world’s first targeted therapy for cholangiocarcinoma (bile duct cancer). The drug, an FGFR2-targeted protein kinase inhibitor, was originally discovered by US biotech Incyte Therapeutics and licensed to Innovent for Greater…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192), spun out from AstraZeneca’s China drug discovery unit in 2017, announced that the National Medical Products Administration (NMPA) has approved a Phase II clinical study for its pipeline candidate DZD1516. The trial will evaluate DZD1516, a small-molecule HER2-targeted tyrosine kinase inhibitor, in combination…
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Hong Kong-based GenScript Biotech Corporation (HKG: 1548) announced that its subsidiary Legend Biotech Corporation (NASDAQ: LEGN) has terminated a Phase I clinical study for LB1901, a chimeric antigen receptor (CAR) T cell therapy candidate targeting CD4. The decision follows the FDA’s clinical hold in February 2022 and the lifting of…
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Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the first patient enrollment in a Phase III clinical study for its core product TAB014, a recombinant anti-VEGF antibody, in neovascular wet age-related macular degeneration (wAMD). The randomized, double-blind, non-inferiority Phase III study is designed to…
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China-based Brii Biosciences Ltd (HKG: 2137) announced the commercial launch in China of the anti-COVID-19 antibody cocktail amubarvimab + romlusevimab. The regimen represents a long-acting neutralizing antibody therapy against COVID-19. The first commercial batch of the antibodies was released today, marking an important milestone in the commercialization of the combination…
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the Biologics License Application (BLA) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has been re-filed with and is under review by the US FDA. The filing covers two indications: Tuoyi’s use in combination with gemcitabine/cisplatin as a first-line treatment of…
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a China-based Phase I clinical study for its drug candidate GZR101. The first-in-human study aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of the GZR101 injection and its component GZR33. Drug Details and…
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HER2 monoclonal antibody (mAb) injection FS-1502 in HER2-expressing advanced gastric cancer patients. The study will evaluate the…
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China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its somatropin to treat Prader-Willi Syndrome (PWS). This latest approval marks the tenth indication for the company’s somatropin and represents the first approval for a home-grown growth hormone…
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China-based Inmagene Biopharmaceuticals and HutchMed (NASDAQ: HCM, HKG: 0013) announced the completion of first patient dosing in a global Phase I clinical study for their IMG-007 in Australia. The drug, an antagonistic monoclonal antibody (mAb) targeting OX40, was discovered by HutchMed. Inmagene owns exclusive global option rights to the drug…
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that an investigational new drug (IND) filing for its in-house developed BCL2 inhibitor ICP-248 has been accepted for review by the National Medical Products Administration (NMPA). ICP-248 is a Category 1 innovative drug with independently held intellectual property rights. Drug ProfileInnoCare plans to…