北京太景 3.35億元人民幣(無形資產) 與 東陽光藥 共組公司 開發口服C肝藥 (DAG-181/ Yimitasvir + TG-2349/ Furaprevir)

東陽光藥設合營從事丙肝新藥研發產銷 東陽光藥(01558)宣布，與太景醫藥(北京)於中國共同設立合營公司，專門從事治療丙肝的新藥研發、生產及銷售業務，註冊資本為6.83億元人民幣(約7.82億港元)。集團出資現金3.48億元人民幣(約4億港元)，太景醫藥(北京)以無形資產投入方式出資3.35億元人民幣(約3.83億港元)，分別佔合營公司註冊資本的51%及49%。於合營公司設立後，集團將以2000萬美元(約1.55億港元)或4000萬元(約3.1億港元)的對價購買太景醫藥(北京)所持合營之9%股權。完成後，集團將於合營持股60%。集團指，其磷酸依米他韋(Yimitasvir Phosphate，亦稱DAG-181)是一個國家1.1類、全新的NS5A蛋白質抑制劑，太景醫藥(北京)的伏拉瑞韋(Furaprevir，亦稱TG-2349)是一個全新的NS3/4A蛋白酶抑制劑。依米他韋和磷酸伏拉瑞韋均為直接作用於病毒的口服治療慢性丙肝病毒感染的藥物。通過是次設立合營公司，將集團之肝病毒NS5A蛋白質抑制劑磷酸依米他韋與太景醫藥(北京)研發之丙型肝炎蛋白酶抑制劑伏拉瑞韋合併，開發新型丙型肝炎全口服免干擾素合併療法，股東協議各方將實現互利合作，提高產品競爭力的同時為中國丙肝患者提供更好的治療手段。根據股東協議，於股權轉讓完成後，倘合營公司從事的伏拉瑞韋和磷酸依米他韋在II期臨床試驗的任一合併劑量組結果顯示，在丙肝患者體內的藥效學數據SVR12(以治療結束後12周時實現持續病毒學應答的受試者所佔比例)達到90%或以上，太景醫藥(北京)有權在III期臨床試驗開展前向集團發出書面通知，以原始對價向集團購回不超過9%之合營公司股權。

 

TaiGen Biotechnology To Establish a New Company With HEC Pharmaceutical in China for Treatment of Chronic Hepatitis C NEWS PROVIDED BY TaiGenOct 30, 2016, 08:18 ET TAIPEI, Taiwan, Oct. 30, 2016 /PRNewswire/ -- TaiGen Biotechnology Co., Ltd. ("TaiGen") announced today that its wholly owned subsidiary, TaiGen Biopharmaceuticals Co. (Beijing), Ltd. has signed an agreement with YiChang HEC ChangJiang Pharmaceutical Co., Ltd ("HEC") to establish a new company ("Newco") in mainland China for the joint development, manufacturing, and commercialization of direct-acting antiviral agents (DAAs) for all-oral interferon-free treatments of chronic hepatitis C virus (HCV) infection in the Greater China region (mainland China, Taiwan, Hong Kong, and Macau). The Newco will be the first of its kind in a cross-strait partnership in the pharmaceutical industry. It also formalized the collaboration in the MOU signed in February 2016. Under the terms of the Agreement, the Newco will be capitalized at RMB 680 million (US$102 million). TaiGen will use the intellectual property rights of furaprevir (TG-2349) in Greater China as contribution in kind for 49% equity in the Newco. HEC will use the intellectual property rights of yimitasvir (DAG-181) in Greater China as contribution in kind and an additional cash investment in exchange for 51% equity in the Newco. TaiGen will be responsible for research, clinical development, and registration and HEC will be responsible for operation, manufacturing, sales and marketing of HCV treatment based on furaprevir and yimitasvir. Upon the establishment of the Newco, TaiGen and HEC will execute a separate share transfer agreement where TaiGen will receive from HEC a sum between US$20 to 40 million based on the Phase 2 clinical trial results. After the share transfer is complete, TaiGen will hold 40% equity and HEC 60% equity in the Newco.TaiGen's furaprevir, a HCV NS3 protease inhibitor, is completing a Phase 2 clinical trial in HCV genotype 1b patients in Taiwan. HEC's yimitasvir, an NS5a inhibitor, has completed in Phase 1 trial in mainland China. Both furaprevir and yimitasvir are DAAs, classified as Class 1.1 by CFDA, and were discovered and developed in-house by TaiGen and HEC respectively. According to the estimates from WHO and IMS, the number of HCV patients in mainland China ranges from 10-40 million making it the largest HCV market in the world. At present, less than 10% of the HCV patients are receiving treatment. This is due to low awareness of the disease and the severe and intolerable side effects of interferon-based treatment. Although all-oral interferon-free DAA-based HCV regiments are already available in many countries, none of these are currently approved in mainland China. To expedite the approval and availability of the revolutionary treatment, China's Center for Drug Evaluation has begun to grant priority review status to HCV drugs in development. Furaprevir was granted priority review in April 2016 and TaiGen is the only Taiwanese firm among the seven companies that receive priority review. Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said "Mainland China remains the largest untapped HCV market. We are confident that combining both drugs and company expertise will accelerate the development of our DAA regiment and become a formidable competitor in the Greater China HCV market. This partnership with HEC will be another significant milestone in TaiGen's history and take TaiGen to the next level."Mr. Show-Chung Ho, Chairman of TaiGen's Steering Committee commented, "TaiGen has a successful track record in clinical development and obtaining market approval in mainland China. HEC has the integrated marketing and distribution channels. The synergy that the two companies and their drugs create will bring tremendous benefits to the HCV patients in this region."

About YiChang HEC ChangJiang Pharmaceutical YiChang HEC ChangJiang Pharmaceutical, a public listed company in the Hong Kong Stock Exchange (1558.HK), focuses on the development, manufacturing and sales of pharmaceutical products in viral infections, endocrine, metabolic and cardiovascular diseases. HEC's leading product, Kewei (oseltamivir phosphate) is the No. 1 selling influenza drug in China from 2013 to 2015. YiChang HEC is part of HEC Pharmaceutical Group. Its products are exported overseas to the US, Japan, Germany and Australia. HEC Pharmaceutical Group is part of the HEC Group with businesses in materials, healthcare, cosmetics, tourism, and hospitality.

About TaiGen Biotechnology TaiGen Biotechnology, a public listed company in Taipei Exchange (4157.TWO), is a leading research-based biotechnology company in Taiwan. TaiGen's pipeline includes other in-house discovered and developed new chemical entities: Taigexyn®, a novel antibiotic, is one of the first NCEs developed by a Taiwanese company that received market approval and launched in Taiwan and mainland China. Burixafor, a chemokine receptor antagonist, is in Phase 2 clinical development for stem cell transplantation and chemosensitization in the US and mainland China.