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Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
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German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to its investigational drug nerandomilast. The drug is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and debilitating lung disease…
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Mirxes Holding Files for Hong Kong IPO with Focus on miRNA Test Kits
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Mirxes Holding Company Ltd, a Singapore – headquartered RNA technology company, has received a filing notice from the China Securities Regulatory Commission (CSRC) regarding its initial public offering (IPO) of 46,620,000 shares in Hong Kong. The company filed its prospectus with the Hong Kong Stock Exchange in November of last…
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Shenzhen Kangtai Halts COVID-19 Vaccine Development Amid Market Shifts
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Shenzhen based biopharmaceutical company Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the termination of its research and development efforts for the COVID – 19 inactivated vaccine (Vero cells). The decision was driven by the evolving nature of the novel coronavirus and the changing market environment for COVID…
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Huadong Medicine’s Ellansé M Filing Accepted by China’s NMPA
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that its market filing for the injectable polycaprolactone-based dermal filler Ellansé M has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company as it seeks to expand its presence in the…
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China Medical System Partners with MabGeek for Innovative Drug MG-K10
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China Medical System Holdings (CMS; HKG: 0867) has announced a new license agreement with MabGeek Biotechnology Co., Ltd., a fellow Chinese biotech firm, for the latter’s Category 1 drug MG-K10. This marks CMS’s second major licensing deal in less than a month. Financial details of the agreement were not disclosed.…
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BioCity Biopharma Launches Phase III Study for Kidney Disease Drug SC0062
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BioCity Biopharma, a leading biopharmaceutical company, has announced the initiation of a Phase III clinical study for its kidney disease drug SC0062 at the Guangdong Provincial People’s Hospital, the leading institution for the study. The study, named SUCCESS-01, aims to evaluate the efficacy and safety of SC0062 capsules in patients…
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ConjuStar Raises RMB100 Million to Advance X-Drug Conjugates Pipeline
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ConjuStar, a specialist in X-Drug conjugates (XDCs) based in Tianjin, has reportedly raised RMB100 million (USD13.73 million) in a Pre-Series A+ financing round. The funding was led by Fosun Health Capital, with participation from Hengqin Venture Capital and Shenzhen Qianhailiyuan Investment. The proceeds will be used to accelerate core product…
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Hengrui’s Long-Acting Insulin Analogue Accepted for Review by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its market filing for a long-acting insulin analogue, a Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Hengrui as it seeks to bring China’s first…
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AbbVie Partners with Neomorph on Molecular Glue Degraders for Oncology and Immunology
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with Neomorph, Inc., aimed at developing novel molecular glue degraders for multiple targets across oncology and immunology. The partnership seeks to leverage Neomorph’s innovative technology to address critical needs in cancer and immune-related diseases. Molecular Glue…
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Sino Medical Sciences Wins Peru Approval for Coronary Balloon Catheter
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving marketing approval from Peru’s Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for its SC HONKYTONK coronary balloon dilation catheter. This marks another milestone in the global expansion of the company’s product portfolio, further solidifying its presence in international…
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Shenzhen Beike Initiates First Chinese Stem Cell Study for Systemic Lupus Erythematosus
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China-based stem cell specialist Shenzhen Beike Biotechnology Co., Ltd has announced the initiation of a Phase I/II clinical study for human umbilical cord mesenchymal stem cells in patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first regulatory study for stem cell therapy targeting SLE in China,…
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Accuray’s Tomo C System Completes Treatment of First 100 Patients in China
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US-based medical device firm Accuray Inc. (NASDAQ: ARAY) has announced the completion of treating the first 100 patients using its Tomo C Radiation Treatment Delivery System at the Shandong Cancer Hospital and Institute. The milestone marks a significant achievement for the Tomo C System, which was developed through the CNNC-Accuray…
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Ascentage Pharma Prices US IPO at USD 17.25 per ADS
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China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) has announced the pricing of its initial public offering (IPO) of 7,325,000 American depositary shares (ADSs) in the United States at USD 17.25 per share, prior to underwriting discounts and commissions. The ADSs are scheduled to begin trading on the Nasdaq Global Market…
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United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA
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Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing for a biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step towards introducing a more…
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Beijing Aosaikang’s ASKB589 Shows Promise in Phase I/II Study for Gastric Cancer
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has unveiled the latest results from a Phase I/II study of its Category 1 biologic product candidate ASKB589, which is being evaluated as a first-line treatment for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma. The study assessed the efficacy and safety of ASKB589 in…
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Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA
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US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies,…
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Novo Nordisk Partners with IMMvention on BACH1 Program for Sickle Cell Disease
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has entered into a strategic collaboration and license agreement with US-headquartered IMMvention Therapeutix, Inc. to develop and commercialize oral therapies targeting the BACH1 pathway for sickle cell disease (SCD) and other chronic conditions. The partnership aims to leverage IMMvention’s expertise in BACH1 inhibition to…
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Zai Lab’s ZL-1310 Granted Orphan Drug Designation by FDA for SCLC
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its ZL-1310, a potential first-in-class DLL3-targeted antibody drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). This designation underscores the drug’s…
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Simnova, Orna Expand Partnership to Develop BCMA-Targeted RNA Therapies
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Shanghai Simnova Biotech Co., Ltd. (Simnova), an affiliate of Simcere Investment Group, has expanded its strategic partnership with Cambridge, Massachusetts-based Orna Therapeutics. The collaboration now includes BCMA (B-cell maturation antigen) as a designated biological target for RNA-based therapeutics development. This partnership aims to leverage Orna’s groundbreaking circular RNA (oRNA) technology…
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Johnson & Johnson Reports Q4 Growth, Projects 2025 Sales Outlook
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has released its Q4 2024 financial results, reporting global sales of USD 22.52 billion, a robust 5.3% year-on-year (YOY) operational growth excluding currency fluctuations. Net profit for the quarter was USD 3.431 billion, down 17.0% YOY. For the full year, annual sales reached…
