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康方生物:全球首个头对头Keytruda单药III期取得PFS优效结果,重申买入评级

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 70.00, indicating a potential upside of 59.1% from the current price of HKD 44.00 [1][2]. Core Insights - The company has achieved positive results in its Phase III clinical trial (AK112-303/HARMONi2) against Keytruda for PD-L1 positive NSCLC, demonstrating a significant improvement in progression-free survival (PFS) [1][2]. - AK112 is the first drug to show survival benefit improvement in a head-to-head Phase III trial against a PD-1 monotherapy, with expected hazard ratio (HR) below 0.7 [1][2]. - The company plans to submit a supplemental application for new indications to the National Medical Products Administration soon [1]. Summary by Sections Clinical Trial Results - The HARMONi-A study reported a median PFS of 7.1 months for the treatment group (AK112 + chemotherapy) compared to 4.8 months for the control group, with an HR of 0.46 (P<0.001) [5]. - Subgroup analyses showed significant PFS benefits across various patient populations, including those with brain metastases and specific mutations [7][9]. Financial Projections - Revenue is projected to grow from RMB 838 million in 2022 to RMB 4,526 million in 2023, with a subsequent decline to RMB 3,097 million in 2024, followed by recovery in the following years [12]. - The net profit is expected to turn positive in 2023, reaching RMB 2,220 million, before experiencing fluctuations in the following years [12]. Market Position - The company is positioned as a leading player in the biopharmaceutical sector, with a market capitalization of HKD 37,983 million and a significant trading volume [3][11]. - The report highlights the company's strong potential in the global market, particularly in the oncology segment, following the successful trial results [2][5].