PD-1/VEGF 双抗伊沃西单药头对头帕博利珠单抗一线治疗PDL1+NSCLC 3 期临床取得PFS 阳性结果，重磅产品潜力凸显。公司将于WCLC 2024 会议上披露依沃西单药对比帕博利珠单抗单药一线治疗PD-L1 表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）的注册性III 期临床研究(HARMONi-2/AK112-303）的具体数据，根据公司公告该研究已获得PFS 阳性结果，本次WCLC 会议披露的具体数据值得期待。海外进展方面，目前合作伙伴Summit 已在海外推进两项全球多中心3 期临床，分别为1）联合化疗vs 化疗治疗经第三代EGFR-TKI 治疗进展EGFR 突变nsqNSCLC 国际多中心3 期临床（HARMONi），2）联合化疗vs 帕博利珠单抗联合化疗1L 治疗sqNSCLC 国际多中心3 期临床（HARMONi-3），未来海外进展值得期待。Incident: The company released its 2024 interim results report. During the reporting period, the company achieved operating income of 1.025 billion yuan, a year-on-year decrease of 72.13%; net profit to mother of -0.239 billion yuan.
Product sales in the first half of 2024 reached 0.94 billion yuan, up 24.0% year on year; of these, PD-1/CTLA-4 dual cardonilizumab achieved sales of 0.71 billion yuan, an increase of 16.5% over the previous year.
Commercialization progressed smoothly, and products such as PD-1/VEGF dual-antibody ivosimonab began to contribute to revenue. The company's core product, PD-1/VEGF, was approved for marketing in May 2024. It was shipped over 100 million yuan by June 30, and is expected to expand further in the second half of the year; another core product, PD-1/CTLA-4, dual cardonilizumab, achieved sales of 0.71 billion yuan in the first half of 2024, an increase of 16.5% over the previous year. Furthermore, in the non-oncology field, IL-12/1L-23 monoclonal antibody is expected to be approved in 2024; PSCK9 monoclonal antibody primary hypercholesterolemia and heterozygous familial hypercholesterolemia indications are expected to be approved in 2024; IL-17 monoclonal antibody moderate to severe psoriasis indications are expected to be NDA in 24; the company's revenue will be further expanded after the above products are approved for marketing.
PD-1/VEGF double anti-ivoxil monotherapy versus pabolizumab first-line treatment of PDL1+NSCLC achieved positive PFS results in phase 3 clinical trials, highlighting the potential for a major product. At the WCLC 2024 conference, the company will disclose specific data from the registered phase III clinical study (Harmoni-2/AK112-303) of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS ≥ 1%). According to the company's announcement, the study has obtained positive PFS results, and the specific data disclosed at this WCLC conference is worth looking forward to. In terms of overseas progress, partner Summit has now promoted two global multi-center phase 3 clinical trials overseas, namely 1) combined chemotherapy vs chemotherapy treatment progressed through third-generation EGFR-TKI treatment, EGFR mutation NSqnsCLC international multi-center phase 3 clinical (Harmoni), 2) combined chemotherapy vs pabolizumab combined chemotherapy 1L treatment with sqnsCLC international multi-center phase 3 clinical (Harmoni-3).
Investment advice: We expect the company's revenue from 2024 to 2026 to be 2.741 billion yuan, 4.609 billion yuan, 6.743 billion yuan, and net profit of -0.366 billion yuan, 0.462 billion yuan, and 1.448 billion yuan respectively, corresponding EPS of -0.4 yuan, 0.6 yuan, and 1.7 yuan respectively; considering the volume potential of the company's marketed/upcoming products and rich clinical research and development pipeline, we It is believed that the company's future development prospects are promising; according to the DCF model, a target price of HK$56.66 for 6 months is given, and the investment rating buy-A level is maintained.
Risk warning: Risk of clinical trials of innovative drugs falling short of expectations, risk of clinical trial failure, risk of pharmaceutical policy changes, risk of product sales falling short of expectations, risk of uncertainty about the development of the epidemic.
