Introduction to this report:
The company's AACR annual meeting revealed first-line gastric cancer data with cardonil, showing the benefits of the entire population, which is expected to drive the evolution of gastric cancer treatment patterns. Major indications for cardonil have been implemented one after another, and Iwasil is about to be approved, maintaining the “increase” rating.
Summary:
Major clinical data released, maintaining an “incremental” rating. Recently, the positive results of the mid-phase III clinical study analysis of the company's core product, cardonil combined chemotherapy for first-line gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, were published in an oral report at the 2024 American Cancer Association Annual Meeting (AACR). The overall data was impressive. The 24-26 revenue forecast was adjusted to RMB 28.96/44.21/6.129 billion yuan (previously RMB 28.96/44.21/5.989 billion yuan), taking into account the rapid release of Cardonelli. Maintain an “Overweight” rating.
Cardonil has benefits for the entire population and is expected to drive the evolution of gastric cancer treatment patterns. In the study data disclosed this time, PD-L1 CPS<5 (low expression) and PD-L1 CPS<1 (negative) were relatively high (49.8%/23%); cardonil brought significant survival benefits for the whole population (MoS was 15.0 vs 10.8 mo, HR = 0.62), especially for people with low PD-L1 expression (MoS is 14.8 vs 11.0 mo, HR = 0.7), which is expected to make up for the current PD-1 monoclonal first-line treatment of gastric cancer with low PD-1 expression Shortcoming with limited efficacy (see attached table).
Major indications for cardonil have been implemented one after another, and Iwasil is about to be approved. Currently, the first-line gastric cancer indication of cardonil is in the NDA stage; the first-line cervical cancer indication has reached the PFS endpoint, and it is expected to reach the OS endpoint and submit an NDA within 24 years. The company's core product, Evosi, has launched a number of registered clinical trials around the world. According to the company's official website, its expected milestones in 2024 include: (1) Q2-Q3 is expected to be approved for listing EGFR-TKI treated NSCLC; (2) Q2 Evosil versus Pabolizumab first-line treatment PD-L1+ delay/metastatic NSCLC registration phase III clinical trials are expected to usher in mid-term analysis (main end point of PFS); (3) H2 evosi+ chemotherapy versus tirelizumab + for first-line chemotherapy late/metastatic squamous NSCLC registration Phase III clinical trials are expected to complete enrollment; (4) Patients were enrolled in an international multi-center phase III clinical study of evasil+chemotherapy for lated/metastatic non-squamous NSCLC that progressed through three generations of EGFR-TKI treatment, led by H2 partner Summit.
In terms of monoclonal antibodies, iroximab (IL-12/23) and inucimab (PCSK9) are in the NDA stage, pluximab (VEGFR2) and gumocimab (IL-17) are in phase III clinical phase, and mandoximab (IL-4R) is about to enter phase III clinical trials.
Catalysts: Excellent clinical trial results; new products approved for marketing; commercial release exceeded expectations.
Risk factors: the risk of uncertainty in the development of new drugs; the risk that commercialization progress falls short of expectations.