山东罗欣药业集团股份有限公司招标公告
中国上海，2021年6月24日 - 罗欣药业集团股份有限公司（以下简称“罗欣药业”）子公司山东罗欣药业集团股份有限公司（以下简称“山东罗欣”）宣布与韩国HK inno.N Corporation（原CJ HealthCare Corporation公司，以下简称“HK inno.N Corporation”）在线签署合作协议，就引进HK inno.N Corporation公司的替戈拉生注射剂产品达成合作。山东罗欣将获得该产品在中国的独家开发、生产和商业化权利。目前，替戈拉生注射剂在全球范围内尚无产品上市。
Shanghai,China, June 24, 2021-- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.(Shandong Luoxin), a subsidiary of Luoxin Pharmaceutical Group Stock Co., Ltd. (Luoxin Pharmaceutical) signed a cooperation agreement with South Korea-based HK inno.N Corporation (formerly CJ HealthCare Corporation) whereby Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Tegoprazan injections in China. At present, Tegoprazan injections are not yet available anywhere worldwide. The signing event took place online.
图为签约仪式现场
替戈拉生是钾离子竞争性酸阻滞剂类药物（Potassium-Competitive Acid Blockers，P-CAB），其抑制酸分泌的作用机制为竞争性结合壁细胞内H+/K+-ATP酶（质子泵）的钾离子结合部位。与传统质子泵抑制剂(PPI)不同，P-CAB可直接抑制H+/K+-ATP酶，而无需在强酸环境下活化。而且，无论H+/K+-ATP酶活化与否，P-CAB均可与之结合。替戈拉生注射剂主要用于治疗胃食管反流、上消化道出血和预防应激性胃黏膜损伤等，具有起效快、作用时间长、酸性条件下稳定、可同时抑制激活和静息状态质子泵等特点。
Tegoprazan, a novel potassium-competitive acid blocker (P-CAB), inhibits gastric H+/K+-ATPase (proton pump) in a potassium-competitive and reversible manner.Different from the traditional proton pump inhibitors (PPI), P-CAB can directly inhibit H+/K+-ATPase without activation in strong acid environments. Moreover, P-CAB can be combined with H+/K+-ATPase whether it is activated or not. Tegoprazan injections have mainly been developed for the treatment of acid-related gastrointestinal diseases such as gastroesophageal reflux disease (GERD) and upper gastrointestinal bleeding as well as for the prevention of stress gastric mucosa injury. The drug has many advantages, including fast onset of action, effectiveness over a prolonged period and stability under acidic conditions that can simultaneously inhibit both activated and resting state proton pumps.
根据IQVIA数据，2020年中国质子泵抑制剂（PPI）药物市场规模约30亿美元，仅次于美国位居全球第二，其中注射剂市场规模约20亿美元，约128亿人民币，占PPI药物市场的60%。根据协议条款，山东罗欣将获得替戈拉生注射剂产品在中国的独家开发、生产和商业化权益，并将向HK inno.N Corporation支付总计不超过500万美元的首付款及销售里程碑付款。
Statistics from IQVIA reveal that China’s PPI market amounted to about US$3 billion in 2020, ranking second in the world just behind the U.S. The market for injections reached nearly 2 billion (approx.12.8 billion yuan), accounting for 60 percent of the total PPI drug market.Under the agreement, Shandong Luoxin will receive the exclusive development, manufacture, and commercial rights of Tegoprazan injections in China, and pay up to US$5 million in total down payments and sales milestone payments.
HK inno.N Corporation代表理事姜碩禧（Kang Seok-hee）表示：“罗欣药业作为我们钾离子竞争性酸阻滞剂类药物在中国的开发合作伙伴，具有消化领域强大竞争能力以及出色的商业能力。我很高兴双方可以达成进一步合作，增加Tegoprazan产品在中国市场价值。”
HK inno.N Corporation CEO Kang Seok-hee said “As the development partner of our P-CAB in China, Luoxin Pharmaceutical has strong competitive and excellent business capabilities in the digestion sector. I am pleased that the two sides have been able to enter into this cooperation with the aim of increasing the value of Tegoprazan in the Chinese market.”
“我们与HK inno.N Corporation公司一直保持良好的合作伙伴关系，愿双方共同探索创新药物的努力早日取得成果，为全球病患提供更有价值的创新疗法，也期待在未来拓展更多合作空间。”罗欣药业董事长兼CEO刘振腾表示。
Luoxin Pharmaceutical chairman and CEO Ryan Liu noted “We have maintained a good partnership with HK inno.N Corporation and hope the joint efforts to explore innovative drugs can pay off as soon as possible and provide more effective therapies to patients worldwide. We are looking forward to further expansion of the cooperation in the future.”
罗欣药业与HK inno.N Corporation（原CJ HealthCare Corporation）合作始于2015年，双方就替戈拉生片在中国境内独家开发、生产及商业化权益达成协议。2017 年 6 月该项目获得临床试验批件，2019年首个III期临床研究结果达到主要疗效终点。目前，替戈拉生片上市申请已获CDE受理。
The collaboration between Luoxin Pharmaceutical and HK inno.N Corporation (formerly CJ HealthCare Corporation) began in 2015, when they reached an agreement on the exclusive development, production and commercial rights of Tegoprazan in China. Clinical trial approval was obtained in June 2017, while the first phase III clinical study results reached the main efficacy end point in 2019. At present, the marketing authorization application for Tegoprazan has been accepted by China's Center for Drug Evaluation (CDE).
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【关于韩国HK inno.N Corporation】
HK inno.N Corporation公司是一家即将在韩国交易所上市的集团公司，已向韩国交易所递交上市申请。自1984年成立以来，凭借其处方药，如肠胃药、抗癌药、循环系统药、糖尿病药及肾药，及非处方药品组合，于韩国药品市场独占鳌头。公司于2018年2月18日被韩国Kolmar Korea Co.,Ltd收购，并于2020年2月6日完成官方注册名称变更，从原CJ HealthCare Corporation正式更名为HK inno.N Corporation。
HK inno.N Corporation is a biotechnology and pharmaceutical company that is the process of applying to launch an IPO on the Korea Stock Exchange. Since inception in 1984, the firm has dominated the South Korean drug market with its lineup of prescription drugs for the treatment of gastrointestinal, kidney and circulatory aliments as well as cancer and diabetes, alongside an over-the-counter drug portfolio. The company was acquired by Kolmar Korea Co., Ltd on February 18, 2018, and completed its official registration for a name change on February 6, 2020, from the original CJ HealthCare Corporation to HK inno.N Corporation.
【关于罗欣药业】
罗欣药业集团股份有限公司（以下简称“罗欣药业”）是集药品研发、生产、贸易及医疗健康服务为一体的大型医药企业集团。跻身发展速度领先的中国制药企业方阵，罗欣药业致力于为客户提供高品质原料药、多剂型药物（片剂、胶囊剂、注射剂等）和医疗健康服务。
罗欣药业连续多年位列中国制药工业百强企业榜单，且多次被评为“制药企业研发实力20强”，已于2019年登陆中国A股市场，股票代码002793。
Luoxin Pharmaceutical Group (Luoxin Pharmaceutical) is a healthcare conglomerate that is engaged in health services as well as the R&D, manufacture and sales of pharmaceuticals. As one of the fastest-growing and leading pharmaceutical companies in China, Luoxin Pharmaceutical is committed to providing customers with high-quality API, multi-agent drugs (tablets, capsules and injections) and healthcare services.
Luoxi Pharmaceutical has been included in the list of China’s top 100 pharmaceutical producers for several consecutive years and been named among the Top 20 Pharmaceutical Companies By R&D Strength multiple times. Its shares were listed on China’s A-share market in 2019, with the stock code 002793.
