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Bio-Thera Solutions Inks Licensing Deal with Dr. Reddy’s for Biosimilar Commercialization
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories Ltd. (BSE: 500124). The deal centers on Bio-Thera’s BAT2206, a biosimilar version of Stelara (ustekinumab), and BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab). Dr. Reddy’s will gain exclusive rights to commercialize…
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Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy. Drug Profile and…
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Bio-Thera Solutions Inks Licensing Deal with World Medicine for BAT2206
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China-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with World Medicine, granting the Turkiye-based firm exclusive distribution and marketing rights to its BAT2206, a biosimilar version of Roche’s Stelara (Ustekinumab). Partnership DetailsUnder the agreement, World Medicine will handle the import, regulatory filing, and sales of the drug…
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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
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Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) autoimmune drug Stelara (ustekinumab), in the US. The drug, developed by South Korea’s Samsung Bioepis Co., Ltd., is approved for the same chronic inflammatory disease indications as the originator. Licensing DealSandoz…
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Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes. Drug ProfileInsulin degludec, a…
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Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
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South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the…
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Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
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Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in…
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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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CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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Bio-Thera Solutions Licenses BAT2506 to Intas Pharmaceuticals for US Market
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that it has entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting the Indian firm exclusive commercialization rights to its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), in the United States. Details of the AgreementUnder the terms of the…
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Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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Henlius Biotech Licenses HLX15 to Dr. Reddy’s for US and European Markets
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a licensing deal with India-headquartered Dr. Reddy’s Laboratories Ltd. (BOM: 500124) for its HLX15, a biosimilar version of Johnson & Johnson’s Darzalex (daratumumab). Under the agreement, Dr. Reddy’s will obtain exclusive commercialization rights to the anti-CD38 monoclonal antibody (mAb), including both intravenous…
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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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Henlius and Abbott Sign License Agreement for Biosimilars and Biologic Drug
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic license agreement with Abbott Laboratories (NYSE: ABT). The agreement grants the US multinational company exclusive or semi-exclusive development and commercialization rights to four biosimilars and one novel biologic drug in 69 emerging countries and regions. The deal, for which…
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Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
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South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license, development, and commercialization agreement focused on Samsung Bioepis’s EPYLLI, a biosimilar competing with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab) on the US market. Under the partnership, Samsung Bio will be responsible for the development, regulatory…
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GlycoNex Licenses SPD8 Biosimilar to Undisclosed Company for Osteoporosis Treatment
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Taiwan-based GlycoNex, Inc. (TPEx: 4168) has announced a licensing agreement with an undisclosed company for its SPD8, a biosimilar version of Amgen’s (NASDAQ: AMGN) Prolia and Xgeva (denosumab). The agreement involves an undisclosed amount of development and commercialization milestone payments, granting the licensee rights to develop, secure regulatory approval for,…
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Mabwell Bioscience Files for IPO on Hong Kong Stock Exchange, Expanding Biopharma Reach
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has officially filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. This move marks a significant step in the company’s growth strategy as it seeks to expand its operations and raise capital for further development. Company Overview and PipelineFounded…
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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…
