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UB Biotechnology Secures Series A Funding for Flow Cytometry Platform
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China-based in vitro diagnostics (IVD) maker UB Biotechnology (Zhejiang) Co., Ltd has reportedly raised “tens of millions” of renminbi in a Series A financing round, led solely by Yuanbio Venture Capital. The proceeds will be directed towards research and development and market development for its flow cytometry technology platform. Company…
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IASO Biotherapeutics Partners with Umoja Biopharma to Evaluate iCIL Platform
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China-based biopharma IASO Biotherapeutics has announced a research agreement with US immuno-oncology company Umoja Biopharma, Inc., to evaluate Umoja’s iCIL platform with IASO’s best-in-class chimeric antigen receptors (CARs). The collaboration aims to develop off-the-shelf therapies for patients with hematological malignancies, initially focusing on acute myeloid leukemia (AML), with the goal…
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Shanghai Unveils Policies to Boost Global Biomedical R&D Hub
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The Shanghai municipal government has released a set of policies and measures aimed at accelerating the establishment of Shanghai as a global biomedical R&D economy and industrialization hub. The initiative seeks to provide improved guidance for financial funding and social capital, enhancing the total economic contribution from biomedical research and…
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WuXi Biologics Launches Integrated Biologics CRDMO Center in Shanghai
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has launched its Integrated Biologics CRDMO Center in the Fengxian district of Shanghai. The new facility will enhance the company’s development and manufacturing capacity, offering end-to-end services for diversified biologics to accelerate project timelines for global clients. This…
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Nona Biosciences Licenses HCAb Technology to Dragonfly Therapeutics
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Nona Biosciences, a newly established wholly owned subsidiary of Harbour BioMed (HKG: 2142), has struck a licensing deal with US firm Dragonfly Therapeutics. The agreement grants Dragonfly rights to use Nona Bio’s heavy chain only antibody discovery platform (HCAb) technology and develop antibodies according to Dragonfly’s designated targets. Financial details…
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Salubris Pharmaceuticals’ SAL0119 Accepted for CDE Review in China
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that its clinical trial filing for the Category 1 drug candidate SAL0119 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of SAL0119, an oral small-molecule immunosuppressant designed…
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Aosaikang’s ASKG915 Accepted for FDA Review, Targets Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that its clinical trial filing for the Category 1 biologic product ASKG915 has been accepted for review by the US FDA. This marks a significant step forward in the development of ASKG915, a bifunctional fusion protein targeting programmed-death 1 (PD-1) and…
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Legend Biotech Receives IND Approval for LB2102 CAR-T Therapy
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC. Clinical Study DesignThe open-label…
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Sun-Novo Pharma Gains NMPA Approval for STC007 Clinical Study in CKD-aP
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007. The study will focus on moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in adults receiving hemodialysis (HD).…
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JD Healthcare Partners with Jiangsu Yuyue for Medical Device Collaboration
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JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), has announced a partnership with compatriot firm Jiangsu Yuyue Medical Equipment Inc. (SHE: 002223). The collaboration aims to leverage JD Healthcare’s healthcare supply chain and service advantages, combined with Yuyue Med’s expertise in the medical device field, to enhance…
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Junshi Biosciences’ JunMaiKang Approved by NMPA for Multiple Indications
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been approved by the National Medical Products Administration (NMPA) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and…
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Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status from the US FDA for its generic version of Bayer’s Gadovist (gadobutrol injection), marking the first generic approval of this kind in the United States. This approval positions Hengrui to expand its presence in the…
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Fosun Pharma’s Bivalent COVID-19 Vaccine Comirnaty Authorized in Hong Kong
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced obtaining emergency use authorization (EUA) in Hong Kong for its bivalent COVID-19 original strain/Omicron variant BA.4-5 vaccine Comirnaty (BNT162b2) as a booster shot for populations aged 12 and above. This marks a significant step in the company’s efforts to provide enhanced…
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IASO Biotherapeutics Reports Positive Phase I Results for CAR-T Therapy in NMOSD
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China-based IASO Biotherapeutics has announced the interim results of a Phase I investigator-initiated-trial (ITT) for its BCMA chimeric antigen receptor autologous T (CAR-T) cell therapy equecabtagene autoleucel (CT103A) in neuromyelitis optica spectrum disorder (NMOSD). The study (NCT04561557) is the world’s first to assess a CAR-T therapy in aquaporin 4 (AQP4)-mediated…
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ViVest Medical Raises Funds for Wearable Cardioverter Defibrillator Development
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Suzhou-based device maker ViVest Medical Technology Co., Ltd has reportedly raised “hundreds of millions” of RMB in a Pre-Series B financing round led by SDIC Unity Capital. Other investors included Dingxin Capital and Anji Liangshan State-owned Holdings. The proceeds will be used to advance a clinical study for its fully…
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Mabwell Receives Approval for Clinical Study of 9MW3011 in Polycythemia Vera
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development. Drug Profile9MW3011…
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China’s CDE, HNMPA, and Bo’ao Lecheng Release Real-world Drug Research Measures
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The Center for Drug Evaluation (CDE), Hainan Medical Products Administration (HNMPA), and Bo’Ao Lecheng Medical Tourism Pilot Zone management bureau have jointly released a set of “Real-world Drug Research Implementation Measures.” The new rules take effect immediately, aiming to streamline the process for conducting real-world studies of clinically urgent imported…
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Hotgen Biotech Receives FDA EUA for COVID-19 Antigen Home Test
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving Emergency Use Authorization (EUA) from the US FDA for its Hotgen COVID-19 antigen home test. This approval marks a significant milestone in the company’s efforts to provide accessible and convenient testing solutions for the novel Coronavirus (2019-nCoV). Test ProfileThe Hotgen…
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Wolters Kluwer Partners with China’s NCID to Advance Infectious Disease Diagnosis
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Holland-based information and software solutions provider Wolters Kluwer has announced a partnership with China’s National Center for Infectious Disease (NCID). The collaboration aims to enhance evidence-based diagnosis and treatment in the infectious disease field through joint efforts in discipline development and talent cultivation. Financial details of the partnership were not…
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Jiangxi Healthcare Security Administration Launches New VBP Tender
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The Jiangxi Healthcare Security Administration (JHSA) has released a notice of a new volume-based procurement (VBP) tender. Jiangxi’s JHSA will lead a 16-region alliance covering Inner Mongolia, Jilin, Heilongjiang, Zhejiang, Henan, Hunan, Guangxi, Hainan, Chongqing, Guizhou, Shaanxi, Qinghai, Ningxia, Xinjiang, and the Xinjiang Production and Construction Corps. This initiative aims…
