Tegoprazan

December 12, 2024 HK inno.N’s K-CAB, new drug for Gastroesophageal Reflux Disease (GERD) treatment, launched in 6 additional Latin American countries Product launch in 6 countries including ▲Dominican Republic ▲Nicaragua ▲Honduras … K-CAB now available in 15 countries worldwide Ranked 3rd in the Mexican market within a year of its launch… market share of 10% in sight HK inno.N announced on 12 December that K-CAB (tegoprazan) for gastroesophageal reflux disease (GERD), was launched in six additional Central and South American countries. The six countries in the region with the recent product launch of K-CAB are ▲Dominican Republic ▲Nicaragua ▲Honduras ▲Guatemala ▲El Salvador ▲Colombia. K-CAB already obtained the marketing authorization under the local product name "Ki-CAB" in September. K-CAB’s bold strides of market expansion in Latin America include 18 countries, either in the form of exporting finished products or technology export. Following its launch in Mexico and Peru last year, the product was released in Chile in the second half of this year and is now launched in 6 more countries in the continent, establishing its market presence across 9 countries of Latin America at a remarkable pace. Carnot, HK inno.N's partner that signed a contract with HK inno.N for exporting and distribution of K-CAB to 17 Latin American countries excluding Brazil, has been active in its marketing campaigns to lead the market growth of K-CAB (the local product name "Ki-CAB.") in the Central and South American markets. As part of the partnership, HK inno.N and Carnot have jointly hosted an academic conference for medical specialists in South Korea and Latin America since the last year. In October this year, a symposium was held in Bogota, Colombia, in celebration of K-CAB’s launch in the country. A number of eminent gastroenterologists from the Americas attended the event, gave presentations, and had lively discussions on the clinical benefits of K-CAB and the areas where it can be used as a new treatment option. Dr David A. Peura, an emeritus professor in gastroenterology at University of Verginia, Charlottesville, the U.S., presented in his lecture at the Colombia symposium, “K-CAB should be considered as an option for all cases of Helicobacter pylori eradication therapy requiring acid suppression.” Dr. Marcelo Vela of the Mayo Clinic in the U.S. reported, “K-CAB has a faster onset of action in suppressing gastric acid than other potassium competitive acid blockers (P-CAB) and has greater benefits than proton pump inhibitors (PPIs) in the treatment of GERD in patients with moderate to severe reflux esophagitis (LA grade B/C/D).” An official from Carnot stated, "K-CAB landed on its position as the top 3 peptic ulcer medicines in Mexico within a year from its launch and is close to achieving the 10% market share," and added, " the rapid pace of growth of K-CAB has had a positive impact on the Latin American market, and medical specialists in other countries in the continent where K-CAM has not been introduced yet have expressed great interest and expectations. HK inno.N’s CEO Dalwon Kwak commented, “K-CAB has quickly gained prominence in the Central and South American market, and our efforts to promote the value of the Korean new drug in the global peptic ulcer market will continue to expand, beyond Latin America.” 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. Recently, the Mexican Association of Gastroenterology (the Asociación Mexicana de Gastroenterología) published a guideline recommending P-CAB class drugs from the early stage in the treatment course of GERD, which is expected to further increase the influence of K-CAB in the market of peptic ulcer medications in Central and South America. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 46 countries worldwide, including the U.S. 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 for this year alone in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for four consecutive years since its launch. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ PPI: Proton Pump Inhibitor ■ The Mexican Association of Gastroenterology: Asociación Mexicana de Gastroenterología ■ Overview of K-CAB’s market presence worldwide (46 countries in total): - South Korea, China, Mongolia, India, South Africa, the U.S, Canada - 6 Southeast Asian countries: Indonesia, Thailand, the Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 10 Middle Eastern/North African countries - 18 Central and South American countries (see below) ■ K-CAB’s market entry to Central and South America includes the following 18 countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador (Of these, Carnot is an exporter for 17 countries, which excludes Brazil). ■ Overview of K-CAB’s market presence in Central and South America - Technology transfer (1 country): Brazil - Product release (9 countries): Mexico, Peru, Colombia, Chile, Dominican Republic, Nicaragua, Honduras, Guatemala, and El Salvador.

11月19日，罗欣药业发布公告，为盘活存量资产、优化公司资源配置，控股子公司山东罗欣拟通过公开挂牌方式出售其全资子公司山东罗欣乐康制药有限公司（以下简称乐康制药）100%股权，确定挂牌价为1.9亿元。 这不是罗欣药业首次转让控股子公司进行自我救赎。在业绩持续亏损、缺乏创新产品的形势下，罗欣药业的前路充满不确定性。 转让控股子公司盘活存量资产 公告显示，乐康制药成立于2018年1月23日，经营范围包括药品生产；药品批发；药品零售；药品委托生产等。2023年度，乐康制药实现营收2291.53万元，亏损4594.96万元；2024年前三季度，乐康制药实现营收1029.35万元，亏损2917.52万元。 罗欣药业称，此次交易有利于盘活资产，优化资源配置，增强盈利能力和抗风险能力，交易完成后，山东罗欣不再持有乐康制药股权，乐康制药将不再纳入公司合并报表范围。 这不是罗欣药业首次转让控股子公司股权。5月22日，罗欣药业公布转让另一控股子公司股权的进度，山东罗欣已收到上药控股子公司上药山东支付的第二期股权转让款7947.37万元，加上此前一期转让款，已合计收到2.86亿元。 该交易可以追溯到2022年9月，罗欣药业董事会同意转让子公司山东罗欣现代物流集团股份有限公司（现更名为上药罗欣医药（山东）有限公司，以下简称上药罗欣)股权的决议——作价4.15亿元，将上药罗欣70%股权转让给上药山东。 记者注意到，截至2022年上半年，上药罗欣的资产总额为24.12亿元，净资产为6.44亿元。而双方协议的上药罗欣价值为5.93亿元。这意味着，罗欣药业子公司出让价不及其净资产。 对于该价格，罗欣药业曾公告称，此次交易价格充分考虑了目标公司实际经营发展情况、医药行业的发展速度及环境变化，定价公允合理，不存在损害公司利益尤其是中小股东利益的情形。 完成交割后，罗欣药业将不再是上药罗欣大股东。彼时，罗欣药业认为，在出让上药罗欣后，公司将聚焦主业，实现资源合理配置，符合长远发展需要。 业绩持续亏损，身陷负面泥潭 公开资料显示，罗欣药业集药品研发、生产、销售及医疗健康服务为一体，以研发和创新作为企业发展的核心动力。2020年4月，罗欣药业拟作价75.69亿元借壳东音股份登陆A股，当时，罗欣药业成为首起港股成功私有化退市后再次在A股借壳上市的案例。 然而，罗欣药业上市后的经营并不乐观。 2020年是罗欣药业正式落户A股的第一个完整财年，彼时，罗欣药业实现营收60.96亿元，同比下降19.67%，实现净利润3.21亿元，同比下降49.41%。营收、净利润双双大降的成绩单令市场大跌眼镜。2022年，罗欣药业净亏损12.25亿元，2023年，净亏损6.61亿元。此前发布的2024年前三季度报告显示，罗欣药业仍未扭转亏损局面，前三季度净亏损2.65亿元。 罗欣药业创始人刘保起2018年在公司30周年庆典上提出了“从现在的百亿企业到今后三十年实现千亿发展”的目标。6年后的今天，罗欣药业甚至没能守住百亿市值，目前公司总市值仅45.57亿元。 今年以来，罗欣药业身陷负面泥潭，违规减持处罚后又被出具警示函，直指三大违规披露问题，紧接着是管理层人员接连辞任，这不禁令人对其内部管理产生疑问。 4月7日，罗欣药业控股股东罗欣控股收到证监会浙江监管局的《行政处罚决定书》，罗欣控股违规减持0.72%股份，浙江证监局决定，对罗欣控股给予警告，并没收其违法所得及罚款共计280.1万元。 这一处罚源于去年12月1日证监会对公司控股股东罗欣控股的减持立案调查。经查，2023年5月至7月，罗欣药业实控人刘保起、刘振腾父子通过罗欣控股等共减持1.71亿股公司股份，套现金额超10亿元，5月18日至24日期间共减持5.72%股份，其中罗欣控股违规减持了罗欣药业0.72%股份，即787.06万股。 今年6月14日，罗欣药业收到山东证监局出具的行政监管措施决定书，要求公司责令改正，并对董事长刘振腾、总经理刘保起、财务总监陈娴、董事会秘书韩风生等责任人出具警示函，记入证券期货市场诚信档案数据库。 根据公告，山东证监局对罗欣药业开展了现场检查，公司存在收入确认执行不一致、重要合同条款披露不完整、关联交易未审议未披露事项等问题。 频繁的人事变动也接踵而至。6月17日，罗欣药业发布公告，监事会职工代表监事刘鸿雁辞职，6月21日，公司证券事务代表朱雪云辞职。 重营销、轻研发，创新药转型“路漫漫” 在创新与研发方面，罗欣药业虽然一直强调“仿创结合”，可实际在研发方面的投入并不算多，一直处于“重营销、轻研发”状态。 2020年至2023年，罗欣药业研发费用分别为3.61亿元、3.21亿元、2.05亿元、1.12亿元，呈逐年递减之势。同期销售费用分别为20.0亿元、18.6亿元、17.30亿元、9.64亿元。 虽然在新品获批方面有所进展，2022年，罗欣药业首款自研P-CAB替戈拉生片获得国家药监局批准，用于治疗反流性食管炎，不过，替戈拉生片并非罗欣药业独立研发，而是引进韩国公司HK inno.N。罗欣药业不仅要向韩国公司支付首付款和里程碑付款合计500万美元，还要支付相应的销售提成。 在仿制药赛道，罗欣药业消化类药品的核心产品为注射用兰索拉唑，同类生产厂家众多，国家药监局官网显示，注射用兰索拉唑目前共41条生产批文，生产企业包括苏州第壹制药有限公司、辰欣药业股份有限公司、悦康药业集团股份有限公司等10多家企业，最早通过仿制药一致性评价的注射用兰索拉唑尚来自奥赛康（002755.SZ），罗欣药业未能把握先机。 11月19日，罗欣药业收于4.27元/股，同比上涨3.14%。 来源：新京报 作者:  张兆慧 商务合作 130 6172 3098 zakk.cui@siqibest.com 点击 阅读原文 了解更多