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ImmuneOnco’s IMM2520 Receives FDA Clinical Trial Approval
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced receiving clinical trial approval from the US FDA for its IMM2520, a bispecific antibody (BsAb) targeting CD47 and PD-L1 in solid tumors. Mechanism of Action and Preclinical ResultsIMM2520, featuring functional IgG1 Fc, can activate macrophages and T cells simultaneously by targeting CD47 and PD-L1…
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Jiangsu Recbio’s COVID-19 Vaccine ReCOV Shows Superiority in Phase II Trial
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the positive results of a Phase II clinical study for its recombinant COVID-19 vaccine ReCOV in the Philippines as a sequential booster shot. The results showed that ReCOV as a sequential booster shot was superior to mRNA vaccine in…
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Treadwell Therapeutics Presents PLK4 Inhibitor Data at ASH Annual Meeting
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China-based Treadwell Therapeutics presented results of the company’s CFI-400945 program, a first-in-class inhibitor of Polo-like Kinase 4 (PLK4), a critical regulator of centriole duplication, at the 64th American Society of Hematology (ASH) annual meeting. The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202…
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Cryofocus Biotechnology’s RDN System Gains FDA Breakthrough Therapy Designation
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Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd’s in-house developed Cryofocus RDN System, a cryoablation renal denervation product, has obtained breakthrough therapy designation (BTD) status from the US FDA for use in refractory hypertension. Regulatory Milestones and InnovationsThe Cryofocus RDN System, the first of its kind globally, previously passed…
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Beijing Releases COVID-19 Infection Drug List to Address Stocking Issues
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The Beijing Municipal Health Commission formulated and released the “COVID-19 infection drug list” (first edition), seeking to alleviate drug stocking issues prompted by the concerns around surging cases in the wake of China dropping all COVID-19 control measures in recent days. Drug List DetailsThe list complements the 9th edition of…
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Cutia Therapeutic Plans IPO on Hong Kong Stock Exchange
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China-based dermatology specialist Cutia Therapeutic announced plans to make an initial public offering (IPO) to the Hong Kong Stock Exchange. Company Background and PipelineFounded in 2019, Cutia Therapeutic boasts a pipeline consisting of 11 products with great market potential, covering hair disease and hair care, skin disease and skin care,…
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China’s State Council Boosts Internet Medical Services Amid COVID-19
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The State Council released a notification in relation to the COVID-19 pandemic, seeking to ramp up Internet medical services as previous lockdown conditions have been unilaterally lifted across the country in the past few days. The key takeaways include: Online Prescriptions and Drug DeliveryMedical institutions (including Internet hospitals and medical…
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Asieris Pharmaceuticals Enrolls First Patient in Phase II Study for APL-1202
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China-based Asieris Pharmaceuticals (SHA: 688176) announced the first patient enrollment in a Phase II clinical study for its oral drug candidate APL-1202 in combination with the PD-1 inhibitor tislelizumab as a neoadjuvant therapy for muscular invasive bladder cancer (MIBC). The open-label, multi-center Phase I/II clinical study is designed to evaluate…
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Jiangsu Yahong Administers First Dose of Hexvix in Hainan Pilot Zone
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) announced the first patient administration of Hexvix (hexyl aminolevulinate hydrochloride) in the Lecheng medical pilot zone in Hainan province. Hexvix is an optical imaging agent used to perform Blue Light Cystoscopy to detect carcinoma of the bladder for…
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Ascletis Pharma Announces Positive Phase I Results for ASC10 in COVID-19 Treatment
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China-based Ascletis Pharma Inc., (HKG: 1672) announced the positive topline results from its Phase I multiple ascending dose (MAD) study (NCT05523141) in healthy subjects for the oral RNA-dependent RNA polymerase (RdRp) inhibitor ASC10 being developed as treatment for COVID-19. The Phase I data demonstrated that all doses of ASC10, including…
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Yantai Dongcheng to Acquire US Firm XingImaging for $30.2M
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) is set to acquire a 100% stake in US-based firm XingImaging LLC for a consideration of USD 30.2 million from sellers Gilles Tamagnan, Molecular Neuroimaging Holdings LLC, Kenneth Marek, Bill (Piu) Chan, David Alagille, Rebecca Evans, and Gu Zhuqin. XingImaging’s Focus…
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Hotgen Biotech’s COVID-19 Antigen Home Test Approved in Russia
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) announced receiving market approval in Russia for its Hotgen COVID-19 antigen home test. The product, used for household testing of novel Coronavirus (2019-nCoV), previously received approvals in the US, the European Union, and the UK. Global Approvals and Market ExpansionHotgen Biotech’s COVID-19 antigen…
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Angel Pharmaceuticals Presents CPI-818 Data at ASH 2022 Annual Meeting
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China-based Angel Pharmaceuticals Ltd announced the latest results of the global Phase I/Ib clinical study for CPI-818, a first-in-class ITK inhibitor co-developed by US partner Corvus Pharmaceuticals, at the American Society of Hematology (ASH) 2022 annual meeting. The study has shown the anti-tumor activities in T-cell lymphoma (TCL), alongside therapeutic…
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ClinBrain and WCH Establish Joint Laboratory for Geriatric Information Platform
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Shanghai-based ClinBrain, a clinical data repository (CDR) and medical big data services provider, together with the National Clinical Research Center for Geriatric Diseases (WCH), announced the establishment of a “joint laboratory of geriatric information platform.” The two will work together on clinical research applications, the construction of a high-quality clinical…
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Wuhan YZY Biopharma Files for IPO on Hong Kong Stock Exchange
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China-based Wuhan YZY Biopharma Co., Ltd, a biopharmaceutical company focused on targeted cancer drugs and drug immunotherapies, has made an initial public offering (IPO) filing to the Hong Kong Stock Exchange. Product Pipeline and R&D FocusYZY Bio, focused on the research and development (R&D) and industrialization of bispecific antibodies (BsAb),…
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JW Therapeutics Presents Carteyva Data at ASH Annual Meeting
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China-based JW Therapeutics (HKG: 2126) presented the latest clinical data on Carteyva (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL) at the 64th American Society of Hematology (ASH) annual meeting. Efficacy and Safety in Relapsed/Refractory Follicular LymphomaIn the pivotal…
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4B Technologies Raises RMB 100M in Pre-Series B Financing Round
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China-based 4B Technologies Investments Ltd, a biotech focused on central nervous system (CNS) drug development, reportedly raised upwards of RMB 100 million (USD 14.3 million) in a Pre-Series B financing round. Dachen Capital led the round, which included contributions from Huaxi Investment, FangSheng Capital, ZGC Co-Innovation Fund, and Tao Capital,…
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Gaush Meditech IPOs on Hong Kong Stock Exchange at HKD 21.4 per Share
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China-based Gaush Meditech Ltd reportedly made an initial public offering (IPO) at the Hong Kong Stock Exchange, priced at HKD 21.4 (USD 2.75) per share. That amounts to an HKD 672 million (USD 86.4 million) take-home. Financial PerformanceGaush generated RMB 1.298 billion (USD 186 million) and RMB 578 million (USD…
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Northeast Pharmaceutical Fined RMB 133M for Monopoly Selling
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Northeast Pharmaceutical Co., Ltd (SHE: 000597) was fined RMB 133 million (USD 19m) by the Liaoning Administration for Market Regulation. The China-based firm was investigated by the bureau in November 2019, when the company was suspected of monopoly selling of levocarnitine active ingredients from November 2018 to June 2019. Investigation…
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Dizal Pharma Presents Golidocitinib Data at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented the latest clinical data on golidocitinib (DZD4205) at the 64th American Society of Hematology (ASH) annual meeting. Global Multi-Center Phase I/II StudyA global multi-center Phase I/II study for golidocitinib in recurrent refractory peripheral T-cell lymphoma (r/r PTCL) included a total of 51…
