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Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
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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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Biotheus Inc.’s PM1009 Bispecific Antibody Enters Clinical Trial Review for Solid Tumors
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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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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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Zhaoke Ophthalmology Enrolls First Patient in TAB014 Phase III Study for wAMD
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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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Brii Biosciences Launches Anti-COVID-19 Antibody Cocktail in China
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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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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Under FDA Review for NPC Treatment
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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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Gan & Lee Pharmaceuticals Doses First Patient in GZR101 Phase I Study
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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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Fosun Pharma’s FS-1502 Gets NMPA Approval for Gastric Cancer Study
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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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GeneScience’s Somatropin Wins NMPA Approval for Prader-Willi Syndrome
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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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Inmagene and HutchMed Dose First Patient in IMG-007 Global Phase I Study
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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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InnoCare Pharma’s BCL2 Inhibitor ICP-248 Accepted for NMPA Review
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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…
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Ascletis Pharma Files IND Application for ASC10 with US FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) announced that it has filed an Investigational New Drug (IND) application for ASC10, an oral RNA-dependent RNA polymerase (RdRp) inhibitor being developed to treat COVID-19, with the US FDA following a pre-IND consultation. Drug ProfileASC10 is an orally bioavailable, double prodrug of the antiviral…
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MabPharm’s CMAB017 Receives NMPA Approval for Clinical Study in Solid Tumors
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Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its Category 1 innovative drug candidate CMAB017 in advanced solid tumors. The trial will include patients with colorectal cancer, head and…
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Hansoh Pharmaceutical’s Generic Ibrance Approved by NMPA
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s Ibrance (palbociclib). The drug can now be used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced…
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Shionogi Files NDA for S-217622 COVID-19 Antiviral Drug in China
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Japan-based Shionogi & Co., Ltd has submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China for its oral antiviral drug S-217622, developed through a joint venture with Ping An Life Insurance Company under the name Ping An-Shionogi Co., Ltd. Drug ProfileS-217622 is an oral…
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InnoCare Pharma’s ICP-490 Receives NMPA Approval for Hematological Malignancies
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Beijing InnoCare Pharma (HKG: 9969) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its targeted protein degrader ICP-490. The drug is approved for use in multiple myeloma (MM), non-Hodgkin lymphoma (NHL), and other hematological malignancies. Drug ProfileICP-490, developed through InnoCare’s molecular glue…
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Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma
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The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA – targeted chimeric antigen receptor (CAR) T cell therapy and Novartis’ Zolgensma (OAV101) have been awarded breakthrough therapy designations (BTDs). Hrain Bio’s BCMA CAR – T cell is indicated for relapsed / refractory multiple myeloma. The…
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PersonGen BioTherapeutics’ TAA06 Receives Clinical Trial Approval for B7-H3 CAR-T Therapy
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The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06, an in-house developed chimeric antigen receptor (CAR)-T cell targeting B7-H3, has obtained tacit clinical trial approval for relapsed/refractory neuroblastoma. This approval signifies that the world’s first B7-H3 CAR-T therapy will enter the regulatory study phase.…
