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Biocytogen Pharmaceuticals Makes HKSE Debut with USD 70 Million IPO
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Sino-US contract research organization (CRO) Biocytogen Pharmaceuticals (Beijing) Co., Ltd has completed an initial public offering (IPO) of 21.76 million shares on the Hong Kong Stock Exchange (HKSE), raising a total of HKD 549 million (USD 69.97 million). Company Overview and Core ProductsFounded in 2009, Biocytogen has a pipeline that…
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CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed…
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Jemincare Licenses Oral Androgen Receptor Degrader to Roche’s Genentech
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China-based Jiangxi Jemincare Group has entered into a licensing agreement with Swiss giant Roche’s Genentech. The deal grants Genentech exclusive global development and commercialization rights to Jemincare’s oral androgen receptor (AR) degrader, JMKX00299, including all related intellectual property rights. Financial TermsUnder the agreement, Genentech will pay a USD60 million upfront…
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Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
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The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research Institute of the Chinese University of Hong Kong jointly released a report titled “Research on the Quality of Life of Chinese SMA Patients.” The report indicates that among patients treated with Biogen’s Spinraza (nusinersen), 76.4%…
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CDE Releases Draft Guidelines for RWE-Backed Drug Registration Applications
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The Center for Drug Evaluation (CDE) has released a notification regarding the “Real-World Evidence (RWE)-backed Drug Registration Application Communication Guidelines” (draft proposal). The draft is open for public feedback for one month. The aim is to provide specific requirements and guiding suggestions for communication between the applicant and the review…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
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BRL Medicine’s BRL-101 Receives Clinical Trial Approval for Beta-Thalassemia
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Shanghai-based BRL Medicine Inc. has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its BRL-101. The therapy is an autologous hematopoietic stem progenitor cell treatment for transfusion-dependent beta-thalassemia. Drug DetailsBRL-101 is a gene therapy developed through BRL’s in-house developed hematopoietic stem cell…
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GenScript Biotech Sues Former CSO Fan Xiaohu for Trade Secret Infringement
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Hong Kong-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has sued its former executive, Fan Xiaohu. Fan is the co-founder and former Chief Science Officer (CSO) of its subsidiary Legend Biotech Corporation (NASDAQ: LEGN). The lawsuit is for infringement of trade secrets and is being brought at the…
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Innovent Biologics Initiates Phase I Study of IBI311 for Thyroid-Associated Ophthalmopathy
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China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI311, an insulin-like growth factor 1 (IGF-1R) monoclonal antibody (mAb). Study DetailsThe Phase I dosage escalation study (CTR20221581) is designed to assess the safety and tolerability of…
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Baidu Health’s Precision Matching Engine Powers Public Hospitals
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China Internet giant Baidu’s one-stop health management platform Baidu Health has updated the status of its precision physician-patient matching engine. The platform is designed to empower public Class 3A hospitals and specialty hospitals via big data and artificial intelligence (AI) technology. It allows accurate matching of specialty services in the…
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WuXi Biologics’ Revenues Surge 63.5% in H1 2022 on Strong CRDMO Growth
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKEX: 2269) published its unaudited interim financial report for the six months ending on June 30, 2022. Revenues increased by 63.5% during the period to RMB7.21 billion (USD1 billion). Growth DriversThe company’s growth drivers include the successful implementation of its…
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MingMed Biotech’s Hong Kong IPO Signals Push for First-in-Class Drugs
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Guangzhou-based MingMed Biotech has officially made an initial public offering (IPO) to the Hong Kong Stock Exchange (HKSE). CICC and Credit Suisse are acting as co-sponsors. Company OverviewThe innovation-driven pharmaceutical company is focused on the self-discovery and development of potential first-in-class (FIC) drugs. These drugs aim to address major unmet…
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Junshi Biosciences’ JunMaiKang Biosimilar Gets NMPA Approval Filing
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China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been accepted by the National Medical Products Administration (NMPA). In addition, the NMPA also accepted a clinical trial filing for…
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Applied Protein Technology Raises Hundreds of Millions in Series B Funding
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Shanghai-based Applied Protein Technology (APT Bio), a biotech company focused on mass spectrometry multi-omics precision medicine, has reportedly raised “hundreds of millions” of renminbi in a Series B financing round. The round was led by Legend Capital. The funds will allow the company to double down on mass spectrometry multi-omics…
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SciClone Licenses Menarini’s Vaborem to Tackle Drug-Resistant Infections in China
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SciClone Pharmaceuticals Inc (Nasdaq: SCLN), a China-based company since going private in 2017, announced a licensing agreement with Italy-based Menarini Group regarding the latter’s novel drug Vaborem (meropenem). Under the agreement, SciClone will obtain development, regulatory, and commercialization rights to the antibacterial drug in China. SciClone will pay Menarini Group…
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Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate ZGGS18. The molecule will be assessed as a treatment for general advanced solid tumors. Drug DetailsZGGS18 is a bispecific antibody (BsAb) targeting vascular…
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Fortune Care Raises Hundreds of Millions in Series B for Elderly Care Expansion
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Fushoukang (Shanghai) Family Services Co., Ltd, also known as Fortune Care, a Shanghai-based smart elderly care services provider empowered by information technology, has reportedly raised “hundreds of millions” of renminbi in a Series B financing round. This follows a Series B round held in December last year, which raised “tens…
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Bio-Heart’s BIOHEART-II Study Meets Primary Endpoint for Bioresorbable Scaffolds
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China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) announced that the BIOHEART-II study for its bioresorbable scaffolds (BRS) product BIOHEART in coronary heart disease has reached its pre-set primary endpoint. Study DetailsThe prospective, multi-center, randomized-controlled study enrolled 431 patients, with Abbott Laboratories’ Xience everolimus-eluting coronary stent as the control.…
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Sihuan Pharmaceutical Restructures with Dual Organization Model
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced a structural reshuffling, setting up a dual organization structure consisting of group headquarters and business platform headquarters. Its subsidiaries Xuanzhu Biopharm Co., Ltd and Jilin Huisheng Biopharmaceutical Co., Ltd, two biopharmaceutical companies, will establish themselves as the new business platform headquarters.…
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Baheal Pharmaceutical Partners with Takeda to Boost Drug Commercialization in China
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China-based health services and distribution giant Baheal Pharmaceutical Group has entered into a partnership with the China unit of Japan-based Takeda Pharmaceutical Co., Ltd. The financial details of the deal were not disclosed. The partnership aims to boost the commercialization of Takeda’s Takepron (lansoprazole), Pantoloc (pantoprazole), and Prevacid (lansoprazole) in…
