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TG ImmunoPharma Gains FDA Approval for Phase I Study of Anti-PVRIG Antibody
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China-based TG ImmunoPharma Co., Ltd has announced receiving the go-ahead from the US FDA to carry out a Phase I clinical study for its TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody, in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F: A Promising Anti-PVRIG Therapeutic…
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Adagene Initiates International Study for ADG126 in Hepatocellular Carcinoma
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China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced the initiation of a randomized, international, multi-center clinical study to assess the effects of its anti-CTLA-4 monoclonal antibody (mAb) ADG126, combined with Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), in first-line advanced hepatocellular carcinoma (HCC).…
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Jiangsu Recbio’s Herpes Zoster Vaccine REC610 Gets Clinical Trial Approval in Philippines
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced receiving clinical trial approval for its new adjuvant recombinant herpes zoster vaccine, REC610, in the Philippines. The randomized, observer-blinded, Shingrix-positive controlled Phase I study is designed to assess the safety and immunogenicity of REC610 in healthy subjects aged…
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Endo International Licenses TLC’s Phase III Nanomedicine for OA Knee Pain
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Ireland-based Endo International plc (NASDAQ: ENDP) has announced a licensing deal between its subsidiary Endo Ventures Ltd (EVL) and Taiwan Liposome Company Ltd (TLC). The agreement centers on TLC’s TLC599, a novel injectable nanomedicine compound currently in Phase III development for osteoarthritis (OA) knee pain. Deal Terms and FinancialsUnder the…
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GenFleet and Merck KGaA Partner on European Clinical Study for KRAS G12C Inhibitor
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China-based GenFleet Therapeutics Inc. has announced a European multi-center clinical study and drug supply agreement with Germany’s Merck KGaA. The collaboration will conduct an open, multi-center, Phase Ib/II clinical study to assess the efficacy of combining GenFleet’s KRAS G12C inhibitor, GFH925, with Merck’s Erbitux (cetuximab) in treatment-naïve advanced non-small cell…
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Blue Sail Medical’s Microcatheter Receives NMPA Marketing Approval
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced obtaining marketing approval from the National Medical Products Administration (NMPA) for its Category 3 medical device microcatheter. This internally developed expanding microcatheter is designed to enhance guide wire support and facilitate guide wire exchange in challenging vascular procedures. Product Features…
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Meihua Medtech Secures Over RMB 100M in Series B Financing Led by Eight Roads and Sunland
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China’s Zhuhai Meihua Medical Technology Co., Ltd, a leading clinical microbiology laboratory overall solutions provider, has reportedly raised over RMB 100 million (USD 14.3 million) in a Series B financing round. The round was led by Eight Roads and Sunland Fund, with contributions from Zhuhai Hi tech Financial Investment and…
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InnerMedical Secures RMB 300M in Series D Funding Led by Green Pine and Simiao
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InnerMedical Co., Ltd, a leading chronic disease diagnosis and treatment solutions provider based in Shenzhen, has reportedly raised close to RMB 300 million (USD 42.9 million) in a Series D financing round. The round was led by Green Pine Capital Partners and Simiao Capital, with participation from Cornerstone Investment, Chengshang…
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Novartis China Establishes Health Development Fund in Boao Lecheng
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Novartis (NYSE: NVS) China has announced the establishment of a health development fund, a significant move aimed at bolstering health development, advancing societal improvement, and facilitating common prosperity in China through national-level charitable activities. Registered at the Boao Lecheng Medical Tourism Pilot Zone, this initiative makes Novartis the first in…
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Henlius’ Serplulimab Receives Orphan Drug Designation in Europe for SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced receiving orphan drug designation (ODD) status from the European Committee for its HanSiZhuang (serplulimab) for the treatment of small-cell lung cancer (SCLC). The programmed death-1 (PD-1) inhibitor, previously awarded ODD status in the US for the same indication, is expected to become the…
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XingImaging and Mitro Biotech Partner for Contract Research Services in China
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US-based XingImaging LLC and China-based Mitro Biotech Co., Ltd have announced a partnership to provide contract research services in China. The collaboration aims to partner with global pharma and biotech companies in the target market, focusing on neuroscience and oncology. XingImaging: Specializing in Radiotracer Production and PET AcquisitionXingImaging, based in…
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Doer Bio and MSD Collaborate on Clinical Trial for Anti-Claudin18.2 Antibody DR30303
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China-based Zhejiang Doer Biologics Co., Ltd has announced a clinical trial collaboration agreement with US major Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to investigate Doer Bio’s anti-Claudin18.2 antibody DR30303 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (GC/GEJ). Under the…
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WuXi Biologics’ Shanghai Subsidiary Removed from US UVL
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) announced that its subsidiary WuXi Biologics (Shanghai) Co., Ltd has been removed from the Unverified List (UVL) by the US Department of Commerce, effective December 16, 2022. Consequently, both of WuXi Bio’s subsidiaries previously on the list have…
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Cryofocus Medtech Set for IPO on Hong Kong Stock Exchange
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China-based Cryofocus Medtech (Shanghai) Co., Ltd, a minimally invasive interventional cryotherapy device maker, is set to make an initial public offering (IPO) of 11.11 million shares to the Hong Kong Stock Exchange, priced at HKD 18.9 (USD 2.43) per share. This amounts to an HKD 210 million (USD 27 million)…
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NMPA Approves SonoScape and Acoustic Life’s Intravascular Ultrasound Products
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The National Medical Products Administration (NMPA) has approved Chinese firms SonoScape Medical Corp’s intravascular ultrasound diagnostic equipment and Acoustic Life Science Co., Ltd’s disposable intravascular ultrasound diagnostic catheter for marketing as innovative products. The two products are used together for the ultrasonic imaging inspection of coronary artery intravascular lesions. Innovative…
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Boehringer Ingelheim’s Spevigo Approved by NMPA for Generalized Pustular Psoriasis
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German giant Boehringer Ingelheim announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Spevigo (spesolimab) to treat generalized pustular psoriasis (GPP) in adults. Notably, the drug, previously awarded breakthrough therapy and priority review statuses in China, took a mere three months after gaining approval in the…
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Acotec Scientific’s NEO-Skater Balloon Approved by NMPA for Intracranial Vessels
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving market approval from the National Medical Products Administration (NMPA) for its intracranial PTA balloon NEO-Skater, designed to improve blood flow perfusion in atherosclerotic intracranial vessels. NEO-Skater: Innovative Design and BenefitsNEO-Skater features an improved lubrication coating on the catheter platform and…
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Tracon Pharmaceuticals Provides Positive Update on Envafolimab Phase II Trial
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China-based Alphamab Oncology (HKG: 9966)’s US partner Tracon Pharmaceuticals (NASDAQ: TCON) has provided an early positive update from a Phase II trial underway for envafolimab, the Alphamab-discovered programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The pivotal ENVASARC trial, being conducted by Tracon in the US and UK, is…
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Sirnaomics Announces Interim Results for STP705 in Phase IIb Study for isSCC
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the interim results of part one of a Phase IIb clinical study for STP705, a therapeutic that combines TGF-β1/COX-2 with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing. The trial is assessing the therapy as a treatment for cutaneous squamous cell carcinoma in…
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Henlius Biotech Initiates Phase I Trial for HLX60 in Australia
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the first subject dosed in a Phase I clinical trial in Australia for its independently developed HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) in combination with Henlius’s innovative in-house anti-PD-1 mAb serplulimab. The trial is assessing the combination in treating general advanced…
