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Kelun Pharma’s SKB264 ADC Receives NMPA Green Light for Phase II Solid Tumor Study
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study in advanced solid tumors. The trial will assess SKB264 in…
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BeiGene’s Tislelizumab Faces FDA Delay Due to Inspection Hurdles
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision on its Biologics License Application (BLA) for tislelizumab (Baizean), a PD-1 inhibitor, citing the agency’s inability to conduct onsite inspections. The BLA, filed in September 2021, sought approval for second-line treatment of esophageal squamous cell…
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Orion Holdings to Build Jining Vaccine Plant in China’s Shandong Province
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South Korea-based conglomerate Orion Holdings Corp. will enter China’s vaccine market by constructing a manufacturing plant in Jining city, Shandong Province. The company signed an agreement with local authorities this week to build a 49,600-square-meter biotechnology complex, with an investment of KRW90 billion ($69 million), set to begin operations by…
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Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
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Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products Administration (NMPA) for reducing chemotherapy-induced myelosuppression (CIM) in adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug, licensed from US biotech G1 Therapeutics, was approved under a prioritized review process. Drug ProfileTrilaciclib, a…
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GenScript ProBio Partners with ACT Therapeutics on CAR-T Cell Therapy Development
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GenScript ProBio, a global Contract Development and Manufacturing Organization (CDMO), announced a memorandum of understanding (MOU) with South Korea’s ACT Therapeutics to collaborate on cell therapy development. GenScript will act as ACT’s global partner, providing plasmid and virus vector services to advance ACT’s chimeric antigen receptor (CAR) T cell therapy…
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Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
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Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for treating inoperable giant cell tumor of tendon sheath. The drug, a CSF-1R inhibitor, is being developed for both tumor and non-tumor indications.…
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HutchMed’s Orpathys-Tagrisso Combo Shows Promise in NSCLC at WCLC
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH Phase II trial results at the World Conference of Lung Cancer (WCLC). The study evaluates the combination of HutchMed’s Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib) in EGFR-mutated, MET-driven non-small cell lung cancer (NSCLC) patients with…
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Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA) has approved its injectable bispecific antibody (BsAb) JS203 for a clinical study in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The drug targets CD20 and CD3, leveraging these antigens to enhance tumor-inhibiting effects. Drug Profile…
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CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
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The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou Ascentage Pharma’s olverembatinib and Roche’s crovalimab. The designations aim to accelerate regulatory timelines for these therapies targeting unmet medical needs. Ascentage’s Olerembatinib Roche’s Crovalimab
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Hengrui Medicine’s SHR-1701 + Ameile Combo Greenlit for EGFR-Mutated NSCLC Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved an open, multi-center Phase Ib/II clinical study of its fusion protein SHR-1701 combined with Ameile (aumolertinib) for EGFR-mutated recurrent or advanced non-small cell lung cancer (NSCLC). Drug ProfileSHR-1701 targets PD-L1 and TGF-βRII,…
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Eucure Biopharma Doses First Patient in YH003 + Keytruda Trial for Mucosal Melanoma
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Eucure Biopharma, a subsidiary of Sino-US contract research organization Biocytogen, announced that the first patient has been dosed in a Phase II clinical study in China for a combination regimen of its CD40 monoclonal antibody (mAb) YH003 with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) and albumin paclitaxel. The trial targets first-line…
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Overland ADCT BioPharma Launches Global Phase III Trial for Zynlonta in DLBCL
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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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Bio-Thera Solutions Doses First Patient in BAT8006 Phase I Study for Solid Tumors
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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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OBI Pharma Halts OBI 888 Trial Over Manufacturing Costs, Shifts Focus to Globo H ADC
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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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CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review
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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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Innovent Biologics’ Pemazyre Becomes First FGFR2 Inhibitor Approved in China
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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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Dizal Pharma’s DZD1516 Receives NMPA Green Light for HER2+ Breast Cancer Trial
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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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GenScript Biotech’s Legend Biotech Terminates LB1901 CAR-T Phase I Trial
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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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I-Mab and MorphoSys License Drugs to HIBio in Global Oncology Deal
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China-based I-Mab (NASDAQ: IMAB) detailed a licensing and equity investment deal between its German partner MorphoSys AG (FSE: MOR; Nasdaq: MOR) and U.S. biotech Human Immunology Biosciences, Inc. (HIBio). Under the agreement, MorphoSys granted HIBio global rights to develop and commercialize two drugs: the CD38 antibody felzartamab and the C5aR1…
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Adicon Holdings and Guardant Health Partner on Genomic Profiling in China
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China-based Adicon Holdings Limited announced a strategic partnership with U.S. firm Guardant Health, Inc. (NASDAQ: GH), a leading precision oncology company, to bring Guardant’s comprehensive genomic profiling (CGP) tests to biopharmaceutical firms conducting clinical trials in China. The deal grants Adicon access to Guardant’s liquid biopsy technology, including the Guardant360,…
