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Mabwell Bioscience’s 7MW3711 ADC for B7-H3 Gets Clinical Trial Approval in China
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its antibody drug conjugate (ADC), 7MW3711, which targets B7-H3. This ADC is set to be assessed as a potential treatment for advanced solid tumors. B7-H3’s Role in Cancer and 7MW3711’s…
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Bayer’s Kerendia Officially Launched in China for Type 2 Diabetes-Related CKD
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German pharmaceutical giant Bayer’s (ETR: BAYN) Kerendia (finerenone), the first nonsteroidal, selective mineralocorticoid receptor (MR) antagonist, has been officially launched in China for the treatment of type 2 diabetes-related chronic kidney disease (CKD). The drug received market approval in June 2022 and was included in the National Reimbursement Drug List…
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Sensview Secures Tens of Millions in Series A+ Funding for X-Ray Detector Tech
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Sensview, a developer of solid-state imaging chips and detector module products based in Chengdu, has reportedly secured tens of millions of renminbi in a Series A+ financing round. The round was led by Matrix Partners, with contributions from Suzhou Industrial Park Zhongyuan Naxing Venture Capital and Leli Capital, as well…
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Nanjing Enrui Kainuo Biotechnology Secures Pre-Series A Funding for Cell Therapy Development
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Nanjing Enrui Kainuo Biotechnology Co., Ltd, a China-based cell therapy developer, has reportedly raised tens of millions of renminbi in a pre-Series A financing round. The round was led by Watere Capital, with participation from Future Invest. The funds raised will be directed towards IND filings, advancing the product pipeline,…
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Shenzhen Salubris Pharmaceuticals Receives FDA Clearance for SAL0119 Clinical Trial
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its small molecule pipeline candidate, SAL0119. The upcoming trial will evaluate SAL0119 as a potential treatment for rheumatoid arthritis, ankylosing spondylitis (AS),…
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Bio-Thera Solutions Receives NMPA Approval for CTLA-4 and PD-1 Inhibitor Combo Study
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its BAT4706, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb), in combination with its programmed death-1 (PD-1) inhibitor BAT1308. The study will focus…
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Shanghai Pharmaceuticals Gets NMPA Green Light for Recombinant Human Adenovirus Type 5 Trial
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Shanghai Pharmaceuticals (HKG: 2607; SHA: 601607), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its recombinant human adenovirus type 5 in the treatment of malignant ascites. The filing for this trial was accepted for review…
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Nanjing Immunophage Biotech’s IPG11406 Approved for SLE Clinical Trial in China
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Nanjing Immunophage Biotech Co., Ltd, a China-based biotechnology company, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed Category 1 pipeline candidate, IPG11406. This small molecule is intended to be assessed as a treatment for systemic lupus erythematosus (SLE)…
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Pyrotech (Beijing) Biotechnology Secures $97.37 Million in Series A Financing
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China-based biotech firm Pyrotech (Beijing) Biotechnology Co., Ltd announced the successful completion of a CNY 700 million (USD 97.37 million) Series A financing round last week. The round was spearheaded by SDIC Venture Capital, with China Venture Capital Fund as a co-leader. New participants in this funding round included China…
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Shanghai Henlius Biotech Announces Executive Leadership Changes
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced significant changes in its executive leadership. Zhang Wenjie, who has been instrumental in the company’s growth since joining in March 2019, has resigned from his position as CEO. Despite this change, Zhang will continue to contribute to Henlius Biotech as the…
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Zai Lab and argenx Report Positive Preliminary Results from Vyvgart Hytrulo CIDP Study
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its Netherlands-based partner argenx SE (NASDAQ: ARGX) have announced preliminary positive results from the ADHERE study. The study assessed the effects of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial is the…
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ObsEva SA Regains Full Rights to Nolasiban After Terminating Yuyuan Biological License Deal
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Swiss biopharmaceutical company ObsEva SA (SIX: OBSN) has announced that it has regained full rights to its pipeline candidate, nolasiban, after the termination of a previous license agreement with China-based Yuyuan Biological Technology. Nolasiban’s Profile and Its Importance in IVF TreatmentNolasiban is an oral oxytocin receptor antagonist that plays a…
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Janssen’s Rybrevant Meets Primary Endpoint in Phase III NSCLC Study
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III confirmatory study for the bispecific antibody Rybrevant (amivantamab). The study focused on patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that harbor epidermal growth factor receptor (EGFR) exon…
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Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment…
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Shanghai Xinhengrui Medical Technology Secures Series A Funding for Heart Failure Device Development
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Shanghai Xinhengrui Medical Technology Co., Ltd, a manufacturer of heart failure devices, has successfully raised close to RMB 100 million (USD 13.95 million) in a Series A financing round. The round was led by IDG Capital, with additional investments from Hygeia Capital and Everest Capital. The funds will be directed…
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Beyond Therapeutics Secures Tens of Millions in Pre-Series A Financing for Ophthalmology and Oncology Pipeline
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Beyond Therapeutics Co., Ltd., a biotechnology company based in Suzhou with a focus on ophthalmology and oncology, has reportedly raised tens of millions of renminbi in a Pre-Series A financing round. The round was led by Ming Bioventures, with contributions from Highpower Industrial and 3D BioOptima. The funds will be…
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Mabwell Bioscience Receives NMPA Approval to Launch 9MW2921 Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its novel antibody-drug conjugate (ADC), 9MW2921. Next-Generation ADC Based on Mabwell’s IDDC Platform9MW2921 is a next-generation ADC that leverages…
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Centre Medical Secures Tens of Millions in Series A Financing to Expand Globally
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Centre Medical, a Hong Kong-based cardiovascular specialized medical services provider, has reportedly raised tens of millions of US dollars in a Series A financing round. Lake Bleu Capital led the investment, with participation from Asia Pacific Medical Group. The funds will be directed towards the company’s globalization strategy, with a…
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TransThera Sciences’ TT-00420 Receives Breakthrough Designation for Cholangiocarcinoma Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s candidate TT-00420 is set to receive breakthrough therapy designation (BTD) for the treatment of unresectable advanced or metastatic cholangiocarcinoma. This designation is for patients whose disease recurs after previous systemic chemotherapy and/or FGFR inhibitor treatment.…
