上半年新启动7 项三期临床试验，其中6 项为公司核心资产卡度尼利、依沃西单用/联用疗法：1H24 公司研发费用为5.94 亿元，同比增长3.4%，主要由于公司启动了7 项新的三期临床试验，包括卡度尼利单药同步/序贯放化疗后非小细胞肺癌、中期肝细胞癌、PD(L)1 治疗进展后2L 胃癌、依沃西 1L 胆道癌、1L 胰腺癌、1L PD-L1+ 头颈鳞癌（和CD47 单抗AK117 联用）、以及AK120 (IL-4Rα) 中重度特应性皮炎。展望全年，随着更多三期临床试验的启动和更多病人的招募，全年研发费用预计将达到13-14 亿元。另外，早期研发方面，3 个候选新药进入临床阶段，包括首个自研ADC 分子AK138D1 (HER3 ADC)、AK135 (IL-1RAP)和AK137 (CD37/LAG3)。管理层认为未来PD-1 双抗+ADC或有潜力成为现有PD-1+化疗治疗进展后的迭代疗法，因此公司未来将积极探索ADC 联用，除前述所说的自研首款ADC 进入临床，自研双抗ADC 也即将进入临床。The company's 1H24 performance was generally in line with market expectations. The company is actively promoting more phase III clinical studies of its core assets, cardonil and evosi. The next major catalyst is the mid-stage analysis data of K drug heads for first-line lung cancer to be announced at the WCLC conference. Maintain a “buy” rating and a target price of HK$63.
1H24's performance was broadly in line with market expectations: the company's 1H24 achieved revenue of RMB 1.02 billion, of which product revenue was 0.939 billion yuan (+24% YoY, +11.1% HoH), including Kaitani's revenue of 0.706 billion yuan (+16.5% YoY, -6.2% HoH), and cooperation revenue of US$80 million (from SUMMIT), which is roughly in line with market expectations; the gross margin of product sales is 91.3% (+1.5ppts YoY, -2.1ppts HoH); net loss to mother was 0.239 billion yuan (VS.1H23:2.53 billion yuan net profit, mainly due to receipt of SUMMIT cooperation payments), which is generally in line with market expectations.
Cash and cash equivalents in hand were $5.69 billion.
Seven new phase III clinical trials were launched in the first half of the year. Of these, 6 were the company's core assets, cardonil and evathib single/combination therapy: 1H24's R&D expenses were 0.594 billion yuan, an increase of 3.4% over the previous year, mainly due to the company's initiation of 7 new phase III clinical trials, including non-small cell lung cancer, mid-stage hepatocellular carcinoma, and 1L PD-1 LD-1 after progression of PD (L) 1 treatment head and neck squamous cell carcinoma (and CD47 single Anti-AK117 combination) and AK120 (IL-4Rα) moderate to severe atopic dermatitis. Looking ahead to the whole year, with the launch of more phase III clinical trials and the recruitment of more patients, the annual R&D expenses are expected to reach 1.3-1.4 billion yuan. Additionally, in terms of early development, 3 new drug candidates have entered the clinical phase, including the first self-developed ADC molecules AK138D1 (HER3 ADC), AK135 (IL-1RAP), and AK137 (CD37/LAG3). Management believes that in the future, PD-1 dual antagonist+ADC may have the potential to become an iterative therapy after the progress of existing PD-1 + chemotherapy treatments, so the company will actively explore ADC combinations in the future. In addition to the first self-developed ADC mentioned above, the self-developed dual-antibody ADC is also about to enter clinical trials.
The company is expected to see a number of data readings in the second half of the year, including the specific mid-term analysis data of Iwasi and K Pharmacovigol's 1L PDL1+NSCLC will be read at the WCLC conference, and Cardonil's 1L CC data is expected to be read in 4Q24. The details of the data readout for the second half of the year include: 1) Eversi (PD-1/VEGF): Chinese Phase 3 AK112-303/HarmonI-2 Test (1L PD-L1+NSCLC) Mid-Term Analysis Data Readout (WCLC'24), Phase 2 AK112-205 Test (Single Use or Combined Use) Lung Cancer New Auxiliary Data Readout (WCLC'24), Phase 2 AK112-206 Test (AK112±AK117) 1L CRC data readout, Phase 2 AK117-203 Test (AK112+AK117+ chemotherapy) 1L TNBC data readout, phase 2 AK117-201 trial (AK112+AK117+ chemotherapy) 1L PD-L1+ head and neck squamous cell cancer data readout (expected 4Q24); 2) cardonil (PD-1/CTLA-4): Chinese phase 3 1L CC data readout (expected 4Q24).
Other catalysts in the second half of the year include: (1) Cardonil and Ivoracil will participate in health insurance negotiations at the end of 2024, and if successfully included, it will greatly promote the release of the two drugs; (2) inucimab (AK102, PCSK9) and iroximab (IL-12/IL-23) are expected to be approved on 2H24.
Maintaining a “buy” rating and a target price of HK$63: Based on updated R&D progress and financial data, we adjusted 2024E net loss to $0.54 billion, slightly lowered 2025E micro profit to $0.22 billion net loss, and slightly lowered 2026E net profit to 1.4 billion yuan, mainly due to adjusting revenue forecasts, fine-tuning gross margin forecasts and increasing R&D expenses. Based on the DCF valuation model (WACC: 9.4%, sustainable growth rate: 3%), we maintain a “buy” rating and a company target price of HK$63.
Investment risks: Commercialization progress falls short of expectations, R&D delays or clinical trial data falls short of expectations, and overseas authorization is not going well.
