Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The National Medical Products Administration (NMPA) has approved the new drug application (NDA) for CT053, a CAR-T candidate for treating relapsed or refractory multiple myeloma (MM) in adults [2][3] - The safety and efficacy of CT053 are highlighted, with an overall response rate (ORR) of 91.7% and a very good partial response (VGPR) rate of 88.3% in clinical trials [3] - The company is expanding into the North American market with ongoing clinical trials and plans for early-line clinical studies [3] - The potential market for relapsed or refractory multiple myeloma is significant, with an estimated 153,000 patients in China in 2023, expected to grow to 266,300 by 2030 [3] - The company has strong in-house viral production capabilities to support commercialization [3] Financial Projections - Revenue forecasts for 2023, 2024, and 2025 are set at 100 million, 150 million, and 360 million yuan respectively, with a significant growth rate anticipated [4] - The company is expected to incur net losses, with projected net profits of -690.16 million, -739.49 million, and -598.43 million yuan for 2023, 2024, and 2025 respectively [4][10] - The earnings per share (EPS) is projected to improve from -1.20 yuan in 2023 to -1.04 yuan in 2025 [10] Market Data - The closing price of the stock is 6.62 HKD, with a market capitalization of approximately 3.81 billion HKD [6] - The company has a price-to-book (P/B) ratio of 1.73 and a debt-to-asset ratio of 16.61% [7][10]
科济药业事件点评：CT053获批上市，看好MM 的商业化前景