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HutchMed Initiates Rolling NDA Submission for Elunate to US FDA
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling submission of a New Drug Application (NDA) to the US FDA for Elunate (fruquintinib) for the treatment of refractory metastatic colorectal cancer (CRC). HutchMed plans to complete the NDA submission in the first half of…
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PCAOB Report Signals Relief for US-Listed Chinese Biotechs
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A report issued last week by the US Public Company Accounting Oversight Board (PCAOB) indicated that the threat of forced delisting for non-compliance has been lifted for US-listed Chinese biotechs. The PCAOB, acting under the remit of the US Holding Foreign Companies Accountable Act (HFCAA), reported that it has successfully…
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Luye Pharma’s Shandong Boan Biotechnology IPOs on Hong Kong Stock Exchange
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd has officially made an initial public offering (IPO) of 10.69 million shares to the Hong Kong Stock Exchange, priced at HKD 19.8 (USD 2.54) per share. This amounts to an HKD 212 million (USD 27.2 million) windfall…
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Simcere Pharmaceutical Completes Enrollment for SIM0417 COVID-19 Drug Trial
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of enrollment of 1,208 patients in a Phase II/III clinical study for its SIM0417, an oral COVID-19 drug candidate being co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. Study…
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Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
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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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Liaoning Publishes Fourth Round of Volume-Based Procurement Winning Bids
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The Liaoning drug and medical consumables centralized procurement website has published the fourth round of volume-based procurement (VBP) winning bids among the “eight provinces and two regions.” The list includes a total of 18 drug specifications with an average price reduction of 59.53%, and is open for public feedback until…
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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)…
