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BeiGene to Present Final PFS Results for Brukinsa at ASH Meeting
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced plans to present the final progression-free survival (PFS) superiority analysis results of the Phase III ALPINE study for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) at the annual American Society of Hematology (ASH) meeting. The study assessed…
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Kunshi Biotechnology and Puheng Technology Partner on 3D NAC-Organ Platform for CAR-Macrophage Screening
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Kunshi Biotechnology (Shenzhen) Co., Ltd and Suzhou Puheng Technology Co., Ltd have entered into a strategic partnership to utilize a 3D NAC-Organ technology platform to establish a high-throughput in vitro screening system for CAR-Macrophage cells. The collaboration aims to enhance the research and development (R&D) of new immunotherapies targeting solid…
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Endoso Life Raises Pre-Series A Funding for High-End Medical Endoscope Development
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Endoso Life, a Hangzhou-based developer of high-end medical endoscope systems and devices, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by BGI Co-Win, with participation from Findowin Capital. The proceeds will be used to support research and development of high-end…
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Vcanbio’s VUM02 Accepted for Review by China’s Center for Drug Evaluation
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product, has been accepted for review by the Center for Drug Evaluation. This marks a significant step forward in…
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Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its human interferon gamma for injection. The therapeutic biologic product can now be used to reduce the frequency and severity of severe infections associated with chronic granulomatosis, an indication…
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InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s…
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Sun-Novo Pharma to Acquire MAH Rights for Azilsartan from Baiao Pharma
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced plans to acquire the Marketing Authorization Holder (MAH) rights to Beijing Baiao Pharmaceuticals Co., Ltd’s generic version of Takeda Pharmaceutical Co., Ltd’s azilsartan (20mg, 40mg) for RMB 36.05 million (USD 5.04 million). The deal is structured to transfer the…
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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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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…
