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Henlius Biotech’s HanBeiTai Biosimilar of Avastin Accepted for CDE Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Center for Drug Evaluation (CDE) has accepted a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), for review. The application is intended for the treatment of recurrent glioblastoma (GBM). Drug ProfileHanBeiTai was first approved in…
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Brii Biosciences’ COVID-19 Antibody Cocktail Effective Against Omicron BA.4/5 and BA.2.12.1
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China-based Brii Biosciences Ltd (HKG: 2137) announced that its anti-COVID-19 antibody cocktail amubarvimab + romlusevimab has demonstrated sustained neutralizing activity against the SARS-CoV-2 Omicron BA.4/5 and BA.2.12.1 subvariants. Study ResultsLive virus neutralization experiments conducted in the US showed that 14 days after dosing, the total plasma concentration of the combination…
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Sihuan Pharma’s Xuanzhu Bio Files for Fulvestrant-Piroxetine Combo in Advanced Breast Cancer
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration (NMPA) has accepted a market filing from its non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd for a combination therapy of fulvestrant and piroxetine in advanced breast cancer. This marks Xuanzhu Bio’s first filing for an…
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SinoPharm CNBG’s F61 Monoclonal Antibody Receives NMPA Clinical Trial Approval
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SinoPharm CNBG Wuhan Institute of Biological Products Co., Ltd’s F61, a recombinant broad-spectrum novel coronavirus monoclonal antibody (mAb), has received clinical trial approval from the National Medical Products Administration (NMPA). Development and ResearchF61 was co-developed by Yang Xiaoming’s team with CNBG and Liang Mifang’s team from the Chinese Center for…
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Henlius Biotech’s Hanquyou Approved in Australia for HER2-Positive Cancers
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Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received marketing approval from Australia’s Therapeutic Goods Administration (TGA) for its Hanquyou (trastuzumab injection, EU trade name: Zercepac). The drug will be marketed under the trade names Tuzucip and Trastucip to treat HER2-positive early breast cancer, HER2-positive locally advanced breast…
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Hengrui Medicine’s SHR-1802 + SHR-1316 Combo Receives NMPA Approval for Solid Tumor Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study of its SHR-1802 combined with SHR-1316 for advanced solid tumors. Drug Profiles Global PD-L1 MarketGlobal PD-L1 products include AstraZeneca’s Tecentriq…
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Betta Pharmaceuticals Enrolls First Patient in BPI-442096 Phase I Study for Solid Tumors
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China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
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Sirnaomics’ STP705 Receives Approval for Liver Cancer Trial in Taiwan
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced that it has received approval from the Ministry of Health and Welfare of Taiwan to conduct a Phase I clinical study of its therapeutic candidate STP705 for advanced liver cancer. Drug ProfileSTP705 is a siRNA (small interfering RNA) therapeutic that leverages…
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GenFleet Therapeutics’ GFH018 Receives CTA Approval for Two Clinical Trials in China
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Shanghai-based biotech company GenFleet Therapeutics announced that two clinical trial applications (CTAs) for its drug candidate GFH018 have been approved in China. GFH018 is a small molecule designed to specifically target and inhibit TGF-ß R1. Clinical Trial Details SignificanceThe TGF-ß signaling pathway is a key target for multiple solid tumors.…
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NMPA Approves Genuine Biotech’s Azvudine for COVID-19, Fosun Pharma Inks Licensing Deal
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China’s National Medical Products Administration (NMPA) has conditionally approved HeNan Genuine Biotech Co., Ltd’s azvudine for the treatment of COVID-19 infection. The drug, originally approved in July 2021 for adult HIV-1 patients with high viral loads, can now be used to treat ordinary COVID-19 adult patients. Licensing AgreementShanghai Fosun Pharmaceutical…
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I-Mab Doses First Patient in Global Phase I Study for TJ-CD4B in Solid Tumors
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I-Mab (NASDAQ: IMAB), a Nasdaq-listed company since 2020, announced that the first patient has been dosed in a global multi-center Phase I clinical study for its TJ-CD4B (ABL111), a bispecific antibody (BsAb) targeting Claudin 18.2 (CLDN18.2) and 4-1BB, in solid tumors including gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, and…
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Rona Therapeutics Licenses Sanofi’s siRNA Platform for Global Development
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Shanghai-based RNA therapeutics specialist Rona Therapeutics has entered into a licensing agreement with French pharmaceutical giant Sanofi, securing exclusive worldwide rights to Sanofi’s siRNA platform of chemical modification and delivery moiety, as well as rights to four pre-clinical candidates targeting undisclosed indications. Deal HighlightsThe agreement significantly expands Rona’s pipeline in…
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Luye Pharma’s LY01005 Meets Phase III Trial Goals in Breast Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for LY01005 in breast cancer treatment has successfully met pre-set endpoints. The study demonstrated that LY01005 effectively controls serum estradiol to postmenenopausal levels, with clinical efficacy comparable to a control drug, achieving a non-inferiority standard. Study DetailsThe…
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Fidia Farmaceutici’s Hyalubrix 60 Shows Promise in Treating Arthropathy at Hainan Hospital
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Italy-based Fidia Farmaceutici S.p.A announced that its Hyalubrix 60, a prefilled syringe with sodium hyaluronate solution for intra-articular injection, has successfully completed treatment in four patients at Hainan General Hospital’s Lecheng branch. Product ProfileHyalubrix 60 is designed to restore the viscoelastic properties of knee and hip synovial fluid. It serves…
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Ascentage Pharma’s Olverembatinib Receives Health Canada Approval for Phase Ib Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from Health Canada to conduct a Phase Ib clinical study of its third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), olverembatinib (HQP1351), for drug-resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Study DetailsThe open-label, multi-center, randomized, global…
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Junshi Biosciences’ Toripalimab Receives EC Orphan Drug Designation for NPC
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name: Tuoyi) has received orphan drug designation (ODD) from the European Committee (EC) for the treatment of nasopharyngeal carcinoma (NPC). This marks the sixth ODD for Toripalimab in the US and Europe, following previous designations for…
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Ji Xing Pharmaceuticals Enrolls First Patient in OC-01 Phase III Study for Dry Eye
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that the first patient has been enrolled in a Phase III clinical study for its OC-01 (varenicline) nasal spray in China. The study aims to evaluate the efficacy and safety of OC-01 in treating dry eye and neurotrophic keratopathy. Drug ProfileOC-01…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR18 Phase II Study for Diabetes and Obesity
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase II clinical study for its Category 1 biologic product GZR18, a novel glucagon-like peptide-1 (GLP-1) receptor agonist designed for once-weekly administration. Study DetailsThe Phase Ib/IIb study will evaluate the safety, tolerability, pharmacokinetics,…
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Sinopep-Allsino Biopharm’s SPN0103-009 Receives NMPA Approval for Diabetes and Obesity Clinical Study
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China-based Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its injectable SPN0103-009 for the treatment of type 2 diabetes and obesity. Drug ProfileSPN0103-009 is a novel, long-acting GLP-1 peptide analog designed for improved stability,…
