Sorafenib approved in Egypt, marking a key milestone for Kexing Pharmaceutical's commercialization in the MENA region

Kexing Pharmaceutical(688136.SH) has made significant progress in the overseas commercialization of its introduced product, Sorafenib Tosylate Tablets. Recently, the product has been successfully approved for market launch by Egypt's Drug Authority (EDA), marking an important achievement for Shan DONG Kexing BIOPRODUCTS Co., Ltd.'s internationalization strategy in the MENA region.

Sorafenib, a globally renowned molecular targeted drug, has been widely used in the treatment of various cancers including liver and kidney cancer since the original drug was approved by the FDA in December 2005. According to market research data from BizVibe Consulting, the global sorafenib market size reached RMB 4.889 billion in 2023.

Further expansion of sellable products in the MENA region

As one of the three most populous countries in Africa and a key economy in the Middle East and North Africa region, Egypt has a vast medical market demand. In recent years, with rapid economic development and increasing government investment in healthcare, Egypt's pharmaceutical market has continued to expand, making it an important overseas market for many Chinese pharmaceutical companies. According to data released by Fitch, Egypt's pharmaceutical sales are expected to reach 152.8 billion Egyptian pounds (approximately 3 billion USD) in 2024 and grow to 218.1 billion Egyptian pounds (approximately 4.3 billion USD) by 2028, representing a compound annual growth rate of 9.6%. In addition to its domestic market, Egypt also exerts significant influence on neighboring regions as a hub connecting Africa and the Middle East.

Last year, Shan Dong Kexing Bioproducts Co., Ltd. reached an overseas commercialization partnership with Beijing Yabao Biopharmaceutical Co., Ltd. (referred to as "Yabao Biologics") for the generic drug sorafenib tosylate tablets, promoting the commercialization of this product in ten initial countries overseas, including Egypt, Peru, and Singapore. Within just one year, registration progress has been achieved. Yabao Biologics' sorafenib tosylate tablets had previously obtained marketing authorization in China and the United States. This recent approval in Egypt will help improve local accessibility to this prominent anti-tumor drug, benefiting more cancer patients.

Egypt localization operations, advancing towards a multinational pharmaceutical enterprise

In recent years, Shan DONG Kexing BIOPRODUCTS Co., Ltd. has continuously achieved breakthroughs in its international expansion, with frequent success in opening new markets and establishing a competitive global pharmaceutical presence in the European Union and emerging overseas markets. The company has established a subsidiary in Egypt, introduced foreign talent, and implemented localized operations to accelerate the market entry of its products. Key products such as bevacizumab and infliximab have already passed GMP on-site audits by Egypt's drug regulatory authority. Going forward, as more high-quality drugs advance through registration processes, this will solidify the product foundation for Kexing's deeper expansion into the MENA market.

In 2025, Shan Dong Kexing Bioproducts Co., Ltd. has been actively advancing its internationalization, building a high-quality pharmaceutical portfolio consisting of biosimilars, advanced complex formulations, and innovative drugs, laying a solid foundation for the comprehensive expansion of its global business. To date, the company has introduced nearly 20 overseas commercialized products. With the successful launch of multiple key products, the long-term value of the multinational pharmaceutical enterprise will gradually emerge.