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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
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Kanghong Pharmaceutical’s NASH Drug KH629 Receives Clinical Trial Implicit Approval in China
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On October 18th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that Kanghong Pharmaceutical (SHE: 002773)’s Class 1 new drug, KH629 tablets, has been granted implicit approval for clinical trials for the treatment of adult non-alcoholic steatohepatitis (NASH).…
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Beijing Biostar Pharmaceuticals Set to Go Public on HKEX with Focus on Oncology Innovation
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On October 18, 2024, the Hong Kong Stock Exchange announced that Beijing Biostar Pharmaceuticals Co., Ltd. is set to go public following a successful hearing. CCB International and CITIC Securities International will serve as joint sponsors for the listing. According to the prospectus, Biostar is a biotechnology company driven by…
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Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
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On October 17, ClinicalTrials.gov reported that Akeso Biopharma (HKG: 9926) has initiated a Phase Ib/II clinical study to evaluate the combination of Cadonilimab (CTLA-4/PD-1 dual antibody) and AK112 (Envafolimab, a PD-1/VEGF dual antibody) with chemotherapy as a first-line treatment for pancreatic cancer. The primary endpoints of the study include safety,…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
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On October 17, Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that its innovative Class 1 national drug candidate, CS231295, for cancer treatment has received acceptance for its clinical trial application (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China (Acceptance Numbers:…
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Pfizer Partners with TRIANA Biomedicines to Develop Molecular Glue Degraders for Oncology and Other Diseases
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Pfizer (NSE: PFIZER), a leading US pharmaceutical company, has entered into a strategic partnership and licensing agreement with Massachusetts-based biotech firm TRIANA Biomedicines. The collaboration aims to develop innovative molecular glue degraders targeting a variety of diseases, with a focus on oncology, according to a press release from TRIANA. Under…
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AstraZeneca Files for Market Approval of Tremelimumab in China for Hepatocellular Carcinoma
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The Center for Drug Evaluation (CDE) has indicated on its website that AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has submitted a market filing for tremelimumab, which is likely intended for the treatment of hepatocellular carcinoma (HCC) in combination with durvalumab. This move suggests a strategic expansion in AstraZeneca’s…
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MicroPort CardioFlow’s Heart Valve Balloon Dilatation Catheter Alwide Plus Gains Mexican Approval
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MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced that it has received market approval for its heart valve balloon dilatation catheter, Alwide Plus, from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in…
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Changshan Biochemical Pharmaceutical Wins Marketing Approval for Enoxaparin in Niger
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval for its enoxaparin in Niger. This development marks an important step for Changshan Bio as it expands the international reach of its pharmaceutical products. Changshan Bio’s enoxaparin is a…
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Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in…
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Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
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Laekna, a Sino-US biotech firm, has announced the commencement of a subcutaneous dosing cohort within its Phase I single ascending dose (SAD) study for the monoclonal antibody drug candidate LAE102, which is under investigation for the treatment of obesity. The study, which is randomized, double-blinded, and placebo-controlled, aims to evaluate…
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Sanofi Invests EUR 300 Million in Joint Venture with Orano Med for Next-Generation Radioligand Therapies
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Sanofi (EPA: SAN), a leading French pharmaceutical company, has entered into a strategic agreement with Orano Med, a subsidiary of the French Orano Group, to enhance the development of next-generation radioligand medicines. The collaboration aims to accelerate the growth of radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting isotopes, which…
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Antengene’s Xpovio Secures Expanded Access in South Korea for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that it has received an additional supplementary New Drug Application (sNDA) approval from the National Health Insurance Service (NHIS) of South Korea for its drug Xpovio (selinexor). This marks Xpovio as the world’s first and only FDA-approved oral XPO1…
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AbbVie’s Vyalev Wins FDA Approval as First Subcutaneous Levodopa Therapy for Advanced Parkinson’s
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev…
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Chongqing Zhifei Biological’s EC Injection Receives Market Approval in Indonesia
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122), a leading biopharmaceutical company based in China, has announced that it has received market approval in Indonesia for its in-house developed Category 1 drug, the recombinant Mycobacterium tuberculosis fusion protein (EC) injection. This development marks an important milestone for the company as it…
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Tencent Invests USD 30 Million in Early Cancer Detection Firm Insighta, Backed by Prenetics
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Prenetics Global Limited (NASDAQ: PRE), a prominent health sciences company with operations in the US and Hong Kong, China, has announced a significant investment of USD 30 million by Chinese internet conglomerate Tencent into Insighta, a Hong Kong-based company specializing in early cancer detection. Insighta represents a substantial joint venture…
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LaNova Medicines Secures RMB 300 Million in Series C1 Financing to Advance Cancer Therapy Pipeline
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the successful completion of a Series C1 financing round, raising RMB 300 million (USD 42.1 million). The funding round was led by Sino Biopharmaceutical Ltd (HKG: 1177), with significant contributions from Shanghai Pudong Venture Capital, Zhangjiang Haoheng Innovative Equity…
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Abbott Laboratories Posts 9.4% Q3 Sales Growth, Driven by Medical Devices and Pharmaceuticals
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Abbott Laboratories (NYSE: ABT), a U.S.-based healthcare giant, has reported its financial results for the third quarter of 2024, highlighting a robust 9.4% year-on-year sales growth in constant currency terms, reaching USD 10.64 billion. The Established Pharmaceuticals segment recorded a 2.7% rise in Q3 to USD 1.406 billion, with emerging…
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Chengdu Baiyu Pharmaceutical Strikes Licensing Deal with Novartis for Unannounced Anti-Tumor Asset
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Chengdu Baiyu Pharmaceutical Co., Ltd., a Chinese pharmaceutical company, has entered into a licensing agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS), according to the Xinhua News Agency. Under this deal, Novartis will acquire the global exclusive rights to develop and commercialize one of Baiyu’s small molecule anti-tumor assets, the…
