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和誉20251013
2025-10-13 14:56
Summary of the Conference Call for He Yu Pharmaceutical Company Overview - He Yu Pharmaceutical focuses on the development of small molecule innovative drugs in the oncology field since its establishment in 2016 [3][5] - The company has two significant business development (BD) collaborations: one with Merck for the CSF-1R inhibitor Pimiatinib and another with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor [3][4] Financial Performance - Total revenue for the first half of the year reached 657 million RMB, primarily driven by an 85 million USD upfront payment from Merck [2][7] - Net profit attributable to shareholders was 329 million RMB, with R&D expenses amounting to 228 million RMB [2][7] - As of the end of the first half, the company had approximately 2.3 billion RMB in cash and liquid financial assets [2][7] Key Products and Clinical Developments Pimiatinib (CSF-1R Inhibitor) - Pimiatinib has received acceptance for NDA submission for the treatment of Tenosynovial Giant Cell Tumor (TGCT) and plans to submit applications to the FDA and EMA [2][8] - Global Phase III clinical data shows an objective response rate (ORR) of 54% at 25 weeks, outperforming existing therapies, with no cholestatic liver injury reported [2][8] - Expected peak sales for Pimiatinib are estimated at 900 million RMB, with a valuation of approximately 9 billion RMB based on a 10x PE ratio [3][15] Ipatasertib (FGFR4 Inhibitor) - Ipatasertib shows an ORR of 36.8% in patients with FGFR19 overexpression in hepatocellular carcinoma (HCC), significantly higher than existing second-line treatments [2][10] - Initial data from a combination therapy with Atezolizumab shows an ORR of 50% for first-line treatment of liver cancer [2][10] - The company plans to complete patient enrollment by 2025 and submit for market approval by 2027, with peak sales expected at 1.5 billion RMB and a valuation of around 4 billion RMB [3][15] Other Products - The company is developing multiple products, including oral PD-L1 inhibitors and PRMT5 inhibitors, with various stages of clinical trials [6][12][14] - The pipeline includes potential products targeting cardiovascular metabolic diseases and autoimmune diseases [13][14] Strategic Partnerships - Collaboration with Merck has resulted in a total of 155 million USD in upfront payments and potential milestone payments of up to 610 million USD for Pimiatinib [2][3] - Partnership with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor has a total contract value of 188 million USD [2][4] Management Team - The company is led by experienced professionals, including Dr. Xu Yaochang and Dr. Yue Hongping, who have held leadership positions in major pharmaceutical companies [5] Future Outlook - The company aims to expand its product pipeline and explore non-oncology areas, leveraging its expertise in small molecules and linker technology [13][14] - Key milestones for investors include upcoming approvals and clinical trial results for Pimiatinib, Ipatasertib, and oral PD-1 inhibitors [16]