Lotus Announces Exclusive Commercialziation Agreement With CKD For Biosimilar Darbepoetin Alfa

• Lotus will be the exclusive distributor, and among the first to launch biosimilar Darbepoetin alfa in selected markets
• With this partnership, Lotus re-emphasizes its focus on Nephrology as a core therapy in key Asian markets by ensuring affordable access to quality medication and maintains growth momentum with another strategic addition to its growing biosimilar pipeline

Lotus Pharmaceutical Co., Ltd. (“Lotus” or “the Company”, Taiwan TWSE ticker: 1795) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) today announced that they have entered into a strategic partnership for biosimilar Darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. This long-term collaboration will provide Lotus the rights to market the product exclusively in Taiwan and South East Asian markets.

Chronic renal failure is among the top causes of death, especially in Asia, with an average prevalence rate of mid-teens around the world and has been identified as a major chronic disease requiring greater attention. Among the current available treatments, NESP is the best-selling second generation epoetin with volumes growing by 15% year-over-year during the last three years and the combined size of Lotus’ markets of interest being US$30M.

Petar Vazharov, Chief Executive Officer of Lotus, commented: ”This newly-executed agreement marks multiple milestones echoing our long term strategy to provide quality and affordable healthcare – this deal not only strengthens our Nephrology franchise in in the region, but also enhances our regional presence by adding more complex products to our growing biosimilars portfolio. This is very much in line with our vision to expand beyond the average “me too” generics and venture more and more towards value creation. We will continue to ensure sustainable growth by both portfolio diversification and market expansion across the region”

Darbepoetin alfa from CKD is the fifth biosimilar products Lotus has in the pipeline. Lotus has the rights of commercializing Bevacizumab and Adalimumab in several Asian countries and has submitted Trastuzumab in Korea, and Teriparatide in both Taiwan and Thailand for marketing authorizations. Lotus’ evolving biosimilar pipeline offers another growth engine complementary to the Company’s well-founded generic business.