山東羅欣藥業集團股份有限公司招標公告
中國上海，2021年6月24日 - 羅欣藥業集團股份有限公司（以下簡稱“羅欣藥業”）子公司山東羅欣藥業集團股份有限公司（以下簡稱“山東羅欣”）宣布與韓國HK inno.N Corporation（原CJ HealthCare Corporation公司，以下簡稱“HK inno.N Corporation”）在線簽署合作協議，就引進HK inno.N Corporation公司的替戈拉生注射劑產品達成合作。山東羅欣將獲得該產品在中國的獨家開發、生產和商業化權利。目前，替戈拉生注射劑在全球范圍內尚無產品上市。
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.
圖為簽約儀式現場
替戈拉生是鉀離子競爭性酸阻滯劑類藥物（Potassium-Competitive Acid Blockers，P-CAB），其抑制酸分泌的作用機制為競爭性結合壁細胞內H+/K+-ATP酶（質子泵）的鉀離子結合部位。與傳統質子泵抑制劑(PPI)不同，P-CAB可直接抑制H+/K+-ATP酶，而無需在強酸環境下活化。而且，無論H+/K+-ATP酶活化與否，P-CAB均可與之結合。替戈拉生注射劑主要用于治療胃食管反流、上消化道出血和預防應激性胃黏膜損傷等，具有起效快、作用時間長、酸性條件下穩定、可同時抑制激活和靜息狀態質子泵等特點。
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.
根據IQVIA數據，2020年中國質子泵抑制劑（PPI）藥物市場規模約30億美元，僅次于美國位居全球第二，其中注射劑市場規模約20億美元，約128億人民幣，占PPI藥物市場的60%。根據協議條款，山東羅欣將獲得替戈拉生注射劑產品在中國的獨家開發、生產和商業化權益，并將向HK inno.N Corporation支付總計不超過500萬美元的首付款及銷售里程碑付款。
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：“羅欣藥業作為我們鉀離子競爭性酸阻滯劑類藥物在中國的開發合作伙伴，具有消化領域強大競爭能力以及出色的商業能力。我很高興雙方可以達成進一步合作，增加Tegoprazan產品在中國市場價值?！?
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.”
“我們與HK inno.N Corporation公司一直保持良好的合作伙伴關系，愿雙方共同探索創新藥物的努力早日取得成果，為全球病患提供更有價值的創新療法，也期待在未來拓展更多合作空間。”羅欣藥業董事長兼CEO劉振騰表示。
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.”
羅欣藥業與HK inno.N Corporation（原CJ HealthCare Corporation）合作始于2015年，雙方就替戈拉生片在中國境內獨家開發、生產及商業化權益達成協議。2017 年 6 月該項目獲得臨床試驗批件，2019年首個III期臨床研究結果達到主要療效終點。目前，替戈拉生片上市申請已獲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).
***
【關于韓國HK inno.N Corporation】
HK inno.N Corporation公司是一家即將在韓國交易所上市的集團公司，已向韓國交易所遞交上市申請。自1984年成立以來，憑借其處方藥，如腸胃藥、抗癌藥、循環系統藥、糖尿病藥及腎藥，及非處方藥品組合，于韓國藥品市場獨占鰲頭。公司于2018年2月18日被韓國Kolmar Korea Co.,Ltd收購，并于2020年2月6日完成官方注冊名稱變更，從原CJ HealthCare Corporation正式更名為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.
【關于羅欣藥業】
羅欣藥業集團股份有限公司（以下簡稱“羅欣藥業”）是集藥品研發、生產、貿易及醫療健康服務為一體的大型醫藥企業集團。躋身發展速度領先的中國制藥企業方陣，羅欣藥業致力于為客戶提供高品質原料藥、多劑型藥物（片劑、膠囊劑、注射劑等）和醫療健康服務。
羅欣藥業連續多年位列中國制藥工業百強企業榜單，且多次被評為“制藥企業研發實力20強”，已于2019年登陸中國A股市場，股票代碼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.
