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LT3001 China region out-Licensed to Shanghai Pharma

Lumosa Therapeutics Co., Ltd. (“Lumosa;” 6535.TWO) announced the successful licensing deal on its LT3001, a novel drug for the treatment of acute ischemic stroke (“Product”), in the China region with Shanghai Pharmaceutical Group Co., Ltd. (“Shanghai Pharma, SHP;” 601607.SS; 02607.HK), one of the top-tier publicly-traded pharmaceutical companies in China. Both companies will collaborate to enter the global market through the sharing of clinical trial data.

According to the agreement, Lumosa will co-develop LT3001 in China with Shanghai Pharma and Lumosa will receive upfront and milestone payments up to CNY260 million (approximately USD37 million); including CNY35 million (USD5 million) in upfront payment upon the completion of Product-related data review process, CNY30 million (USD4.3 million) upon the first subject enrollment in the global phase 3 trial, CNY15 million (USD2.1 million) upon the completion of successful global phase 3 trial and the issuance of the study report; CNY180 million (USD25.7 million) upon any regulatory approval of the Product in the US, Europe or China. In addition, Lumosa may receive up to CNY28 million (USD 4.0 million) in sales milestones and 6%~12% royalty payment from the sales of the Product.

To accelerate the development of LT3001 in major pharmaceutical markets such as the US, Europe and Japan, Shanghai Pharma will provide Lumosa with clinical trial data from the Chinese studies to support the global clinical development of LT3001. For that, Lumosa will pay Shanghai Pharma 3%~10% of LT3001 licensing incomes from other regions of the world depending on the development stage of LT3001 in China.

Being one of the top notch publicly-traded pharmaceutical companies in China, Shanghai Pharma reached annual revenue of CNY160 billion (USD22.8 billion) in 2018 and its product line includes cerebro-cardiovascular drugs. The company has worked with many international pharmaceutical companies in product licensing or collaboration on high value-adding drug developments.  In 2018, Shanghai Pharma invested CNY1.06 billion (USD151.10 million) on research and development. Acquiring LT3001 would complement Shanghai Pharma’s product pipeline, and generate synergistic effects in pharmaceutical development, manufacturing and marketing.

LT3001 is a novel small molecule designed for the treatment of acute ischemic stroke with patent protection at least until June 2034. Animal studies have demonstrated LT3001’s multiple functions in promoting vessel recanalization and reduction in reperfusion injury.  Once approved and successfully marketed, the drug will bring hope to vast patients having acute ischemic stroke. LT3001 has patents granted in China, the US, Japan, Australia, and Russia; patents in other major markets are under review by respective national authorities.

Brain stroke is a disease that the medical community is desperately trying to overcome because of its rapid onset and with extremely high disability rate which has caused tremendous social burden. According to the World Health Organization (“WHO”) statistics, approximately 15 million to 17 million people in the world suffer stroke each year. Of which, more than 80% of the patients have acute ischemic stroke.

According to the “Report on Stroke Prevention and Control in China (2018),” there are 12.4 million stroke sufferers over the age 40, almost 2 million die from brain stroke each year. The morbidity and prevalence rates increase every year. Yet, ideal medication or therapy for the treatment of brain stroke is still lacking and the medical need is still not satisfied.

Current medication approved for the treatment of brain stroke is a thrombolytic agent. However, due to its short treatment window of 3.5 hours, numerous side effects and use limitations, the drug is not being widely prescribed. In China, a survey conducted by China Drug Information Center in 2018 in hospitals showed that thrombolytic agents only account for 6.35% of all medications applied. While the use of recent-developed intra-arterial thrombectomy is restricted to be used in larger vessels, together with constrains in the availability of the equipment in the hospitals and the number of well-trained surgeons, the application of thrombectomy is further limited. Therefore, a new drug is still the top choice for the medical community.

“Shanghai Pharma is heavily involved in the cerebro-cardiovascular market. With years of experiences in the clinical developments, manufacturing, marketing and sales promotion, they are the best partner for LT3001. Working with Shanghai Pharma could have synergistic effect in accelerating the research and development of LT3001 for the treatment of the stroke patients all over the world” stated Lumosa Chairman, Dr. Chang-Hai Tsai.

Lumosa’s CEO, Mr. Jung-Chin Lin indicated, “the global medical community has been longing for a new drug for the treatment of brain stroke. The collaboration between Lumosa and Shanghai Pharma could be the first step in realizing this dream as this collaboration will combine the resources and the strength from both sides. Shanghai Pharma’s willingness to share clinical trial data with Lumosa will significantly shorten the time needed to market LT3001 in the US, Europe and Japan, and to create a world-class blockbuster new drug.”

Lumosa has completed the phase 1 human trial of LT3001 in the US, proving the safety and tolerability of the drug. Phase 2 trial is currently being conducted in the US and Taiwan. The trials are anticipated to complete in 1.5 years. Clinical trial package will soon be submitted to China’s National Medical Products Administration for approval in order to start the clinical trial and shorten the time needed to market LT3001.