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China-based diabetes specialist MicroTech Medical (Hangzhou) Co., Ltd (HKG: 2235) has announced plans to conduct an initial public offering (IPO) of 93.46 million shares on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The listing price remains unknown at this stage. Company ProfileFounded in 2011, MicroTech Medical specializes in diabetes…
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China-based Gracell Biotechnologies Inc’s (Nasdaq.GRCL) FasTCAR technology platform has been named the winner of this year’s Fierce Life Sciences Innovation Award. The announcement was made by Gracell CEO William Wei Cao during the firm’s Q3 earnings conference call. The FasTCAR platform enables the “next-day manufacture” of autologous chimeric antigen receptor…
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has entered into another manufacturing cooperation agreement with Indonesia-based PT Etana Biotechnologies (Etana) for PCV and HPV vaccines. This builds on an earlier agreement for Etana to provide local manufacturing of Walvax Bio’s COVID-19 mRNA vaccine in Indonesia. Financial details of the partnership…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the establishment of a licensing agreement with Swiss firm Idorsia Ltd, securing exclusive development and commercialization rights to Idorsia’s insomnia therapy daridorexant in Greater China, including mainland China, Hong Kong, and Macau. The agreement also includes clinical research and development (R&D) activities.…
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced key changes to its C-suite, effective as of November 15, 2022. These leadership moves reflect the company’s strategic focus on growth and operational excellence. CFO PromotionYe Yongji, former China Chief Financial Officer (CFO), has been promoted to group CFO, vice-president…
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China-based Jiangsu Hengrui Pharmceuticals (SHA: 600276) has announced positive results from the randomized, double-blind, placebo-controlled, multi-center RSJ10333 (QUARTZ3) Phase III study for SHR0302 in atopic dermatitis. The study, conducted by Hengrui’s subsidiary Reistone Biopharma Co., Ltd, has reached the pre-set primary efficacy endpoint. Study DetailsThe RSJ10333 study was designed to…
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its Category 1 innovative eye injection KH631 and a generic version of Acadia Pharmaceuticals Inc’s pimavanserin. The approvals are for the treatment of neovascular (wet) age-related macular…
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Shanghai-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced positive preliminary results from the TORCH-2 study (NCT04337463) for its mTORC1/2 inhibitor ATG-008 (onatasertib) in combination with the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) for recurrent/metastatic cervical cancer. The company also released data from the TORCH study for ATG-008 monotherapy in…
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The acute myeloid leukemia (AML) public welfare project, initiated by the China Social Welfare Foundation (CSWF) and sponsored by CStone Pharmaceuticals (HKG: 2616), has officially been launched. This initiative aims to raise awareness and support for AML, a disease that disproportionately affects the elderly and progresses rapidly. AML ContextAcute myeloid…
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that its clinical trial filing for BPI-D0316, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been accepted for review by the National Medical Products Administration (NMPA). The filing is for the drug’s use as a postoperative adjuvant therapy for…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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Junovabio, a Shanghai-based molecular diagnostics specialist, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by Shenzhen Jinsheng Equity Investment Management Co., Ltd. The proceeds will be used for the clinical filing of its first tumor molecular diagnosis product, product clinical…
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China-based Lupeng Pharmaceutical Ltd has reportedly raised USD 35 million in Phase 2 of a Pre-Series B financing round. The round was led by Kaitai Capital and Temasek, with participation from Lilly Asia Ventures, Fontus Capital, and Lake Bleu Capital. The proceeds will be used to support clinical studies for…
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Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb’s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info & Tech analysis. The approvals mark significant milestones for both drugs…
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The Chinese state-owned Silk Round Fund (SRF) and Indonesia’s sovereign fund INA have reportedly agreed to invest in two Indonesian pharmaceutical companies in a deal valued at around IDR 1.86 trillion (USD 120 million). The target companies are PT Kimia Farma Tbk (IDX: KAEF) and its subsidiary, PT Kimia Farma…
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant…
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CStone Pharmaceuticals (HKG: 2616) has officially responded to recent news reports regarding the suspension of manufacturing operations at its Suzhou plant. The company stated that the decision to temporarily halt operations at the Suzhou facility is aimed at reducing operating costs, as the plant is still in the trial operation…
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed hepatitis B virus RNA (HBV RNA) assay kit, utilizing the PCR fluorescence probe method. This approval marks a significant milestone for Hotgen in expanding…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…