2022-09-19

Fosun Pharma and Carephar Enter into a Global Collaboration to Co-develop and Exclusively Commercialize China's First Self-Developed P-CAB Product Keverprazan Hydrochloride

(September 19, 2022, Shanghai, China)Shanghai Fosun Pharmaceutical (Group) Co., Ltd.(“Fosun Pharma”, Stock Code: 600196.SH; 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China, announced that its subsidiary Shanghai Fosun Pharmaceutical Industry Development Co. Ltd. (“Fosun Pharma Industry”) and Jiangsu Carephar Pharmaceutical Co., Ltd. ("Carephar") have entered into an agreement on the joint development and Fosun Pharmaceutical Industrial’s exclusive commercialization of Keverprazan Hydrochloride (R&D code: H008, "Collaborative Product"). The collaboration scope includes all available indications of Keverprazan Hydrochloride oral drug product and common injection. The two sides will collaborate worldwide.



According to the Agreement, Carephar is the marketing authorization holder of the Collaborative Product and Fosun Pharma Industry enjoys the exclusive right to commercialize in the Chinese Mainland (excluding Hong Kong SAR, Macau SAR and Taiwan region, the same below), including marketing promotion and distribution. In the countries and regions outside the Chinese Mainland, Fosun Pharma Industry is the marketing authorization holder of the Collaborative Product and enjoys exclusive rights relevant to the Collaborative Product, including but not limited to clinical study, registration, commercialization, sublicense, etc.


Keverprazan Hydrochloride is China's first self-developed potassium-competitive acid blocker (P-CAB), which is indicated for the treatment of duodenal ulcer, reflux esophagitis and Helicobacter pylori infection. In terms of function, the drug can overcome many defects such as slow onset of action and unstable acid inhibition of the most widely used proton pump inhibitors (PPIs) in clinical application.


Up to now, two Phase 3 clinical studies on Keverprazan Hydrochloride Tablets for duodenal ulcer and gastroesophageal reflux have been completed in the Chinese Mainland. Carephar has submitted the marketing application for two indications of Keverprazan Hydrochloride Tablets to National Medical Products Administration (NMPA) in September 2021 and is currently under review and approval of the Center for Drug Evaluation (CDE), NMPA. In the United States, one Phase 1 clinical study of Keverprazan Hydrochloride Tablets has been completed. In addition, Keverprazan Hydrochloride Injection has been approved by the NMPA to conduct a Phase I clinical study in China in May 2022.


"We are pleased to collaborate with Carephar to promote the joint development and commercialization of Keverprazan Hydrochloride around the world. As the first P-CAB innovator drug independently developed in China, Keverprazan Hydrochloride is expected to bring a new treatment option to patients.” said Wu Yifang, Chairman of Fosun Pharma,“Fosun Pharma continues to be patient-centered and clinical needs-oriented, with an open R&D ecosystem, and practices internationalization strategies in multiple dimensions such as innovative R&D, license-in, production operation and commercialization. Relying on industry-leading License-In & Out capabilities, Fosun Pharma will help to maximize the value of partners' innovative products. In the future, we will make full use of our innovation capacity, internationalization advantages and commercialization ability accumulated over years, and strive to improve drug accessibility, so that patients can benefit from this domestic innovative drug as soon as possible."


Qin Yinlin, Chairman of Carephar,said: "We are very pleased to collaborate with Fosun Pharma, a leading pharmaceutical company in China, to jointly develop and commercialize Keverprazan Hydrochloride globally. We look forward that with its internationalization strength and commercialization capabilities, Fosun Pharma can enable patients worldwide to benefit from this domestic innovative drug as soon as possible and to achieve win-win progress for all."


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About Fosun Pharma

Founded in 1994,Shanghai Fosun Pharmaceutical (Group) Co., Ltd.("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.


Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well ascentral nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.


Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.


For more information, please visit our official website:www.fosunpharma.com.


Fosun Pharma Forward-looking statements

This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including, without limitation, the discussions of Fosun Pharma’s business strategies and expectations concerning future operations, margins, profitability, liquidity and capital resources, the future development of Fosun Pharma’s industry and the future development of the general economy of Fosun Pharma’s key markets and any statements preceded by, followed by or that include words and expressions such as “expect”, “seek”, “believe”, “plan”, “intend”, “estimate”, “project”, “anticipate”, “may”, “will”, “would” and “could” or similar words or statements, as they relate to Fosun Pharma’s or its management, are intended to identify forward-looking statements. These statements are subject to certain known and unknown risks, uncertainties and assumptions, which may cause Fosun Pharma’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking information. Subject to the requirements of applicable laws, rules and regulations, Fosun Pharma does not have any and undertakes no obligation to update or otherwise revise the forward- looking statements in this press release, whether as a result of new information, future events or developments or otherwise. In this press release, statements of or references to Fosun Pharma’s intentions are made as of the date of this press release. Any such intentions may change in light of future developments. All forward-looking statements contained in this press release are qualified by reference to the cautionary statements set out above.


About Carephar

Jiangsu Carephar Pharmaceutical Co., Ltd. was established in June 2006. Since its establishment, Carephar has always taken technological innovation and product R&D as the core, focused on cardiovascular, cerebrovascular, digestive diseases and chronic diseases, committed to the R&D and commercialization of high-clinical-value innovative drugs, and gradually constructed the product layout for the cardiovascular/cerebrovascular diseases, new targets of gastric acid inhibitors, new mechanism-related P-CAB, stem cell and immune cell therapy.


Carephar has 7 innovative drugs in the clinical stage, with the class 1 new drug, Keverprazan Hydrochloride, as a representative. Another key area for Carephar, the stem cell drug DK001, which is primarily used to treat perianal fistulas in Crohn's disease, is in clinical research stage. Carephar also has a number of highly selective small molecule targeted drugs and a series of innovative drugs for immune cell therapy to solid tumors.


Rooted in Nanjing and targeted to the world, Carephar takes "your health, we care from the heart" as its mission, insists on the goal of patient-centered and clinical needs-driven under the core concept of "committed to innovation with professional talents", and keeps revolution ahead. Carephar has always been devoted to becoming a progressive enterprise with industry influence and social value.


For more information about the Company,please visit http://www.carephar.com/.