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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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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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Shenzhen TargetRx Raises Hundreds of Millions in Series B Financing for Drug Development
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China-based Shenzhen TargetRx, Inc., a developer of small-molecule kinase inhibitors, reportedly raised “hundreds of millions” of renminbi in a Series B financing round, with investors undisclosed. The proceeds will go towards pivotal clinical studies for TGRX-678 and TGRX-326, development of other drug candidates, and product pipeline expansion. Company and ProductsFounded…
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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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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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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.…
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Akeso Biopharma’s Cadonilimab Achieves National Delivery in China
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China-based biotech Akeso Biopharma (HKG: 9926) announced the national delivery of its cadonilimab (AK104), marking a commercial launch just six days after approval. The drug, conditionally approved in China on June 29th, is a self-discovered bispecific antibody (BsAb) indicated for the treatment of recurrent or metastatic cervical cancer that has…
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Junshi Biosciences Receives FDA Approval for PI3K-α Inhibitor RP903 in Breast Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study of its PI3K-α inhibitor RP903 (JS105) in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative, PIK3CA-mutated advanced or metastatic…
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NHC Releases Technical Guidelines for Drug Clinical Evaluation
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The National Health Commission (NHC) has released the “Technical Guidelines for Comprehensive Clinical Evaluation of Cardiovascular Drugs,” “Technical Guidelines for Comprehensive Clinical Evaluation of Antineoplastic Drugs,” and “Technical Guidelines for Comprehensive Clinical Evaluation of Children’s Drugs” (all 2022 trial versions), effective as of July 1, 2022. BackgroundThe NHC released the…
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Abbisko Therapeutics Doses First Patient in ABSK061 Phase I Study for Solid Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the first patient dosing in a Phase I clinical study for its ABSK061, an oral highly selective FGFR2/3 inhibitor, in solid tumors. The molecule is described as the first of its kind globally to reach the clinical stages. Study DetailsThe study,…
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Bio-Thera Solutions’ BAT8010 Receives NMPA Approval for Solid Tumor Clinical Trials
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2…
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Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer…
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Burning Rock Biotech Launches PREVENT Study for Early Cancer Detection
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Chengdu-based medical device firm Burning Rock Biotech Ltd (NASDAQ: BNR) announced the launch of a ground-breaking interventional validation study focused on the application of its early cancer test, OverC, in detecting various cancer types in asymptomatic patients. The PREVENT (Prospective multi-canceR Early-detection and interVENTional) study will enroll 12,500 individuals to…
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BeiGene’s Tislelizumab Shows Survival Benefit in Esophageal Cancer Study
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BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously…
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Ascentage Pharma’s APG-5918 Receives FDA Approval for First-in-Human Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a first-in-human clinical study of its embryonic ectoderm development (EED) inhibitor APG-5918. The study will assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced…
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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKG: 1801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
