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Kexing Biopharm’s GB05 Receives FDA Approval for Pediatric RSV Infections
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its human interferon α1b inhalation solution, GB05. The drug is designed to treat pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as…
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Kexing Biopharm and Bio-Thera Solutions Form Alliance for Global Expansion
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China-based Kexing Biopharm (SHA: 688136) and Bio-Thera Solutions Ltd (SHA: 688177) have formed a strategic alliance to explore international pharmaceutical markets. The partnership aims to leverage the companies’ respective strengths in research and development, manufacturing, and commercialization. Financial details were not disclosed. Bio-Thera’s PortfolioBio-Thera has four marketed biologic drugs: Two…
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Kexing and Kelun Partner to Expand Overseas Business for Generic Drugs and Therapies
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China-based firms Kexing Pharmaceutical (SHA: 688136) and Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) have agreed to collaborate on the overseas business development of Kelun’s high-end generic drugs and innovative therapies. The partnership aims to leverage the strengths of both companies to expand their global footprint. Agreement DetailsUnder the terms…
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Kexing Pharmaceutical Partners with Shandong Boan for Biosimilar Commercialization in Hong Kong and Macau
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a commercialization cooperation agreement with fellow Chinese firm Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The partnership aims to promote the marketing and sales of Shandong Boan’s biosimilars BA6101 and BA1102 in Hong Kong and Macau. BA6101 is a biosimilar version of…
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MabPharm’s CMAB807 Biosimilar Infliximab Approved in Pakistan
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J, NYSE: JNJ)’s Remicade (infliximab), in Pakistan. This follows similar approvals in Peru and Indonesia last year. The approval encompasses all six indications, which…
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MabPharm’s CMAB807 Biosimilar Receives Market Approval in Indonesia and Peru
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Taizhou-based MabPharm Ltd (HKG: 2181), a specialist in monoclonal antibody (mAb) biosimilars, has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Remicade (infliximab), in Indonesia, with a similar approval in Peru in July this year. The approval encompasses all six…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Kexing Pharmaceutical Secures NMPA Approval for Childhood Growth Hormone Deficiency Study
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Kexing Pharmaceutical (SHA: 688136), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study targeting childhood growth hormone deficiency. The clinical trial will investigate a Category I innovative product candidate, an Fc fusion protein designed as a long-acting growth hormone. This molecule…
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Kexing Pharmaceutical Secures Global Rights for Qingfeng’s Generic Olaparib
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China’s Kexing Pharmaceutical (SHA: 688136) has secured a global commercialization licensing agreement with Qingfeng Pharmaceutical Group for the latter’s generic version of olaparib. Under this deal, Kexing will obtain commercial rights for the product across an initial batch of 10 international markets. Meanwhile, Qingfeng’s generic formulation is currently awaiting regulatory…
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Kexing Pharmaceutical Secures Rights for Chia Tai Tianqing’s Generic Ibrance in 11 Countries
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Kexing Pharmaceutical (SHA: 688136), based in China, has entered into an international collaboration agreement with fellow Chinese firm Chia Tai Tianqing, securing commercialization rights for Chia Tai’s generic version of Pfizer’s Ibrance (palbociclib). This agreement encompasses an initial batch of 11 countries. Palbociclib, recognized as the world’s first CDK4/6 inhibitor,…
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Kexing Pharmaceutical Partners with Yabao to Distribute Generic Nexavar in Ten Countries
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into an overseas cooperation agreement with fellow domestic firm Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) to distribute a generic version of Bayer (ETR: BAYN)’s Nexavar (sorafenib). Under this agreement, Kexing will serve as the exclusive agent for the tyrosine kinase inhibitor (TKI)…
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Kexing Pharmaceutical Enters Global Licensing Agreement with Xiling Lab for Eribulin Generic
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a global licensing and supply agreement with fellow domestic firm Xiling Lab for the commercialization of its generic version of the breast cancer treatment eribulin, originally marketed as Halaven by Eisai. The agreement grants Xiling commercial and supply rights in 36 countries,…
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Convalife Pharmaceuticals Gets NMPA Approval for Generic Neratinib Clinical Study
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Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
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Kexing Pharmaceutical Secures Commercial Rights for Convalife’s Neratinib Generic Outside China
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China-based Kexing Pharmaceutical (SHA: 688136) has announced a licensing agreement with compatriot firm Convalife, securing commercial rights to the latter’s generic version of Puma Biotechnology Inc’s neratinib in six countries outside China. This move expands access to the oral irreversible small molecule pan-HER tyrosine kinase inhibitor (TKI) for patients in…
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Kexing Pharmaceutical Initiates Phase I Trial for IFN-Alpha-1b Inhalation Solution
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China-based Kexing Pharmaceutical (SHA: 688136) has announced the enrollment of the first subject and dosing in a Phase I clinical study for its interferon-alfa-1b (IFN-alpha-1b) solution for inhalation. The drug will be assessed for treating lower respiratory tract infections caused by respiratory syncytial virus (RSV) in children, including conditions such…
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Tonghua Dongbao Licenses Biosimilar Victoza to Kexing for Emerging Markets
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced a licensing agreement with compatriot firm Kexing Pharmaceutical (SHA: 688136), granting the latter exclusive commercialization rights to its biosimilar version of Novo Nordisk’s Victoza (liraglutide) in 17 emerging markets (EMs). Victoza: Background and ApprovalVictoza, a human glucagon-like peptide-1 (GLP-1) analogue, was first approved…
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Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
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Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
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China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
