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Frontier Biotech and Asymchem Partner on COVID-19 Drug FB2001 Development
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China-based Frontier Biotechnologies Inc. (SHE: 200342) announced a strategic partnership with Asymchem Laboratories (Tianjin) Co., Ltd (SHE: 002821), a Contract Development and Manufacturing Organization (CDMO), to advance the development of FB2001, its COVID-19 3CL protease inhibitor. The collaboration covers R&D, manufacturing, regulatory filing, and production support for pivotal clinical trials.…
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Hangzhou DAC Biotech Doses First Patient in DXC007 AML Study
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing in a Phase I clinical study of its antibody drug conjugate (ADC) DXC007 for relapsed/refractory (r/r) acute myeloid leukemia (AML). The open, multi-center, dosage escalation and expansion trial will assess the drug’s safety, tolerability, and pharmacokinetics. Drug…
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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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Huadong Medicine’s Biosimilar Victoza (Liraglutide) Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide), produced by subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, has been accepted by the National Medical Products Administration (NMPA). The drug is intended as an adjunctive therapy for adult…
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Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for efgartigimod, the world’s first FcRn antagonist, targeting generalized myasthenia gravis (MG). Drug ProfileEfgartigimod, developed by Netherlands-based Argenx and licensed to Zai Lab in January 2024 for up…
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Zhejiang Medicine’s ARX305 ADC Receives Clinical Trial Approval for CD70-Positive Cancers
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) announced that its subsidiary NovoCodex Biopharmaceuticals Ltd has received approval to conduct a clinical study of ARX305, a Category 1 biologic drug targeting CD70 and AS269, for advanced tumors. The drug is designed to treat CD70-positive cancers, including renal cell carcinoma and multiple…
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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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Eli Lilly’s Trulicity + Insulin Combo Meets Goals in China’s AWARD-CHN3 Study
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Eli Lilly (NYSE: LLY) announced that its Phase III AWARD-CHN3 study of Trulicity (dulaglutide) combined with titrated insulin glargine in Chinese patients with type 2 diabetes met the primary endpoint and all key secondary endpoints. The 28-week trial showed significant reductions in glycated hemoglobin (HbA1c), body weight, and fasting serum…
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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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Hengrui Medicine’s SHR8554 Accepted for NMPA Review in Postoperative Pain
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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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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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Gan & Lee Pharmaceuticals’ GZR4 Ultra-Long-Acting Insulin Receives Clinical Trial Approval
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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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VivaVision Biotech’s VVN539 Enters Phase II Trial for Open-Angle Glaucoma in US
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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…
