HK inno.N Corp.

消化系统用药中，抑酸药是大品种的摇篮。早期的H2受体拮抗剂，西咪替丁、雷尼替丁、法莫替丁都是当年的热销品种。后来，质子泵抑制剂上市，凭借绝对碾压的疗效优势，很快就成为市场主导，诞生了奥美拉唑、艾司奥美拉唑、兰索拉唑等全球重磅药品。特别是在国内市场，多个PPI类药物百花齐放，撑起将近400亿市场规模，培育了罗欣、奥赛康、扬子江、丽珠等专注PPI类药物的企业。数据来源：摩熵医药然而，随着国采不断推进，主流PPI类药物陆续被国采，仿制药价格大幅下降，注射剂单价从50多元，下降到个位数，口服剂型也只剩几毛钱一片，整体市场缩水一半。奥美拉唑、泮托拉唑、兰索拉唑、艾司奥美拉唑等，逐步从医院畅销药榜单中消失。质子泵抑制剂医院市场TOP10排名，2024年H1相比2018年，已彻底换了个样。数据来源：摩熵医药相关企业排名方面，丽珠凭借艾普拉唑的强劲表现，2024年H1医院市场销售，断层式遥遥领先。数据来源：摩熵医药在集采政策影响下，抑酸药市场，已经风光不再，但面对巨大的市场规模，企业不会轻言退出。于是，大家发起了新一轮的市场争夺战。首先是H2拮抗剂药物。准入属性完美的法莫替丁、雷尼替丁，还有非医保的罗沙替丁，抓住政策空档期，老树发新芽，销售额暴涨，成就了一批企业和代理商。数据来源：摩熵医药不过随着罗沙替丁被国采，法莫替丁多家企业过评，国采在即，外加全国价格治理，这一波市场热度，预计很快就会消退。其次是PPI类复方制剂拉唑类单方口服制剂太卷，就有企业就开发复方制剂。最早获批的是奥美拉唑碳酸氢钠胶囊，此后又有奥美拉唑碳酸氢钠干混悬、兰索拉唑碳酸氢钠胶囊、艾司奥美拉唑碳酸氢钠胶囊获批。但是，受医保准入以及适应症限制，此类产品的总销售额在2021年达到高峰后，就开始下降，2023年医院市场不足1亿元，这在巨大的抑酸药市场里，已无足轻重。数据来源：摩熵医药第三个是PPI的异构体艾司奥美拉唑剔除了奥美拉唑的R型异构体，只保留S型异构体，取得了巨大成功。于是，其它PPI也可以如法炮制。右旋兰索拉唑和左旋泮托拉唑就是国内企业的重点开发目标。2022年，南京优科的注射用右兰索拉唑首家获批，2024年奥赛康第二家获批，产品也通过国谈进入医保，但由于价格较低，市场销售并不理想，2024年上半年，医院市场销售不足600万元，未来增长潜力有限。而左旋泮托拉唑，虽有企业提交上市申请，但此产品还需要三期临床，离产品获批上市还有较长时间。数据来源：摩熵药筛小程序最后，有钱的企业，都来卷P-CAB抑制剂。P-CAB抑制剂也就是钾离子竞争性酸阻滞剂，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，阻止胃酸分泌。相比拉唑类PPI药物，疗效上略有优势。国内已有多个企业，瞄准了这类产品。伏诺拉生伏诺拉生是全球首个上市P-CAB抑制剂，由武田和大冢联合开发，2015年最早在日本获批，2019年获批进口，2020年进入医保后快速放量，2023年医院市场销售额已超过6亿元。数据来源：摩熵药筛小程序国内仿制药企业快速跟进，一拥而上，目前已有10多个仿制获批，还有140多个上市申请处在审评中。可以想象，等到2026年原研专利到期，市场竞争会是什么格局！数据来源：摩熵药筛小程序需要关注的是，在今年3月，柯菲平独家提交了注射液2类新药上市申请，这个要是能获批，倒是非常有竞争力。数据来源：摩熵药筛小程序替戈拉生2015年，罗欣从韩国的HK inno.N公司，买了替戈拉生片的国内市场开发权益，2022年获批上市，当年就通过医保谈判。2024年上半年医院市场销售超过1亿元。凯普拉生凯普拉生片是有柯菲平开发，销售权给了复星医药，2023年2月获批上市，市场销售刚刚起步。利那拉生2024年12月，上海生诺的戊二酸利那拉生酯胶囊获批上市。这个品种是贵州生诺医药从瑞典的Cinclus Pharma引进，后来又卖给了上海医药。获批适应症是反流性食管炎，市场也刚刚起步。另外扬子江药业买了韩国大熊的非苏拉生片，2023年报产，预计很快也能获批。丽珠买了韩国Onconic的Zastaprazan（又名为JP-1366），目前还在三期临床中。未来，P-CAB抑制剂必将是抑酸药的主战场。用摩熵药筛小程序，随时查询新产品！

March 24, 2025 HK inno.N Acquires Stake in Japan-Based Drug Discovery Company RaQualia - HK inno.N Acquires 10.61% Stake in RaQualia Through Third-Party Allotment - RaQualia, Founded by Former Pfizer Researchers, Licensed K-CAB Compound to HK inno.N in 2010 - Companies to Expand Collaboration Through Joint R&D and Strategic Partnerships in Japan HK inno.N (CEO Dalwon Kwak) announced on the 24th that it has signed an agreement to acquire newly issued shares in RaQualia (CEO Masaki Sudo), a Japanese drug discovery company, through a third-party allotment. With this acquisition, HK inno.N becomes RaQualia’s largest shareholder. Through the agreement, HK inno.N has acquired 2,592,100 shares, representing a 10.61% equity stake in RaQualia. The two companies plan to deepen their strategic partnership by jointly developing new drug pipelines, including efforts to introduce K-CAB to the Japanese market. RaQualia was established in 2008 by former researchers from Pfizer Japan. In 2010, the company licensed the K-CAB compound-a novel treatment for gastroesophageal reflux disease (GERD)-to HK inno.N. RaQualia currently boasts a diversified pipeline of 18 drug candidates, spanning therapeutic areas such as gastrointestinal disorders, pain, and oncology. Its technologies encompass a broad range of modalities, including antibodies, gene and protein therapies, and small-molecule drugs. “We believe this equity investment in RaQualia will open the door to closer collaboration between our two companies in drug research and development,” said Dalwon Kwak, CEO of HK inno.N. “We also plan to actively pursue new business opportunities, including the introduction of K-CAB into the Japanese market,” he added. Several compounds developed by RaQualia, including K-CAB, have been out-licensed and are currently marketed across four products in both human and veterinary medicine. (END) [Reference Information] ▶Animal health products developed by RaQualia (marketed by Elanco Animal Health Inc. in the U.S.) GALLIPRANT® (active ingredient: grapiprant) – a treatment for osteoarthritis in dogs ENTYCE™ (active ingredient: capromorelin) – an appetite stimulant for dogs ELURA™ (active ingredient: capromorelin) – a treatment for weight loss associated with chronic kidney disease in cats

January 6, 2024 HK inno.N’s K-CAB, new drug for Gastroesophageal Reflux Disease (GERD) treatment, enters Australian and New Zealand markets Signed a finished product export agreement for K-CAB with Southern XP, an Australian pharmaceutical company K-CAB has now entered 48 countries worldwide, including the US, China and Latin America... aiming for market entry into 100 countries by 2028 K-CAB, HK inno.N’s new drug for gastroesophageal reflux disease (GERD), is expanding its presence into Australian and New Zealand markets. HK inno.N announced on Monday (January 6th) that the company recently signed an agreement for exporting finished products of K-CAB tablets (active ingredient tegoprazan), its new GERD treatment, to Australia and New Zealand with Southern XP, an Australian pharmaceutical company. Under this agreement, Southern XP will hold exclusive rights to obtain regulatory approval and for commercialization of K-CAB in Australia and New Zealand. The agreement is applicable to the two products: ▲K-CAB tablet 50 mg and ▲K-CAB tablet 25 mg. Southern XP is based in Australia with over 20 years of experience in the pharmaceutical industry, specializing in obtaining the regulatory approvals for and distribution of pharmaceuticals in Australia and New Zealand. The pharmaceutical markets in the two countries are valued at approximately KRW 22 trillion in total as of 2023, of which the market for peptic ulcer medications is valued at about KRW 150 billion. HK inno.N’s CEO Dalwon Kwak commented, “The value of K-CAB as a new drug of South Korea is recognized across different continents worldwide, showing a steady increase in the product’s influence in the global market of peptic ulcer medications” and added, “With the target of market entry into 100 countries worldwide by 2028, K-CAB’s global competitiveness will continue to grow.” K-CAB, the 30th new drug of South Korea, is a P-CAB class new drug for GERD treatment. It is characterized by rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to six months. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 48 countries worldwide, including the US and China. The product has been officially released in 15 countries to date, demonstrating its growing global market presence. K-CAB recorded a total outpatient prescription sales of KRW 177.7 billion from January to November of 2024 in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for five consecutive years. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ Source on the size of the Australian/New Zealand pharmaceutical market and peptic ulcer medications market: IQVIA data, 2023 ■ Overview of K-CAB’s market presence worldwide (48 countries in total): - South Korea, China, Mongolia, India, South Africa, the United States, Canada, Australia, New Zealand - 6 Southeast Asian countries: Indonesia, Thailand, Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 18 Central and South American countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, El Salvador - 10 Middle Eastern/North African countries ■ Countries with official product release of K-CAB (15 countries in total): South Korea, China, Philippines, Mongolia, Mexico, Indonesia, Singapore, Peru, Chile, Colombia, Dominican Republic, Guatemala, El Salvador, Nicaragua, Honduras