Core Insights - The Chinese innovative drug market is experiencing strong growth, with product licensing totaling nearly $66 billion in the first half of 2025, particularly in the rare disease treatment sector [1] - The industry anticipates that entering markets with more established payment systems, such as Europe and the U.S., will help distribute R&D costs and balance commercial and social value [1] Company Overview - Huayi Lekan, founded by biologist Rao Yi in 2019, focuses on gene therapy drug development, with its leading product being a gene therapy for Hemophilia A [1][2] - GS1191 is the first domestically approved clinical gene therapy drug for Hemophilia A, with Phase III clinical trials expected to complete patient enrollment within the year [2] Market Strategy - The initial overseas market chosen by the company is Saudi Arabia, due to its significant number of hemophilia patients and favorable economic conditions for high-priced new drugs [2] - The company is exploring registration advantages in Saudi Arabia, where it can use Chinese clinical data for international multi-center studies [2] Clinical Development - Chinese companies may complete clinical trials faster due to a larger patient base, potentially reducing the time to market compared to international competitors [3] - The recruitment of patients for rare disease drugs can be challenging, but the hemophilia patient organization network is well-developed, facilitating information dissemination [3][4] Patient Demographics - Most recruited patients are under 40 years old, showing a higher willingness to engage with gene therapy and a strong desire for improved treatment options [4] - The company has reported no spontaneous bleeding issues in patients tracked for up to four years under effective dosing [4] Cost Advantages - The lower clinical development and production costs in China provide a competitive pricing advantage for domestic drugs, with GS1191 priced significantly lower than existing therapies [4] - The high cost of rare disease drugs is a common issue globally, creating opportunities for Chinese companies to expand into international markets [4] Regulatory Engagement - The company is in close communication with Saudi regulatory authorities to expedite the registration process for GS1191 and is encouraged to apply for local innovation funds [5] - In addition to rare diseases, the company is also developing products for common neurological diseases and is preparing for a new round of financing [5]