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信达生物(1801.HK):收入快速增长 WCLC/ESMO数据更新值得期待

Cinda Biotech (1801.HK): Rapid revenue growth, WCLC/ESMO data update is worth looking forward to

西南證券 ·  Aug 29

Performance summary: The company achieved operating income of 3.95 billion yuan (+46.3%) in the first half of 2024, and realized a net profit loss of 0.39 billion yuan to mother.

Product revenue grew rapidly, and net losses, excluding net exchange gains and the impact of one-time income tax credits, narrowed.

Product revenue for the first half of 2024 reached RMB 3.81 billion, an increase of 55.1% year over year. The significant increase in revenue was mainly due to Dabershu? (Cindilizumab injection) and the outstanding performance of other products, as well as the accelerated growth and contribution of new products. The increase in losses was mainly due to a decrease in net exchange gains from non-cash items and a reduction in one-time income tax credits. Net losses excluding this effect narrowed.

The company launched 1 new innovative drug, and 6 NDAs are under NMPA review.

An innovative drug was added to the market, and the commercial product was expanded to 11: China's first KRAS G12C inhibitor, Dabert? (Fluzalecide tablets) has been approved for marketing to treat patients with advanced NSCLC with the KRASG12C mutation who have received at least one type of systematic treatment.

Six NDAs were reviewed in the NMPA: two NDAs for IBI344 (tarretinib, ROS1) for 1L and 2L indications; cindirizumab injection combined with fruquintinib for second-line treatment of patients with advanced endometrial cancer; weight management of IBI362 mast peptides, two NDAs for type 2 diabetes; and IBI311 (tetuulizumab, IGF-1R monoclonal antibody) to treat patients with thyroid eye disease.

Retinib is expected to be approved for marketing in the second half of the year, and it is worth looking forward to updated data on several key varieties such as IBI363. In the second half of the year, IBI344 (ROS1 inhibitor, tarretinib) is expected to be approved for marketing, and IBI112 (IL-23p19) is expected to be submitted for NDA. The company will verbally report the world's first (PD-1/IL-2α-Bias) phase 1 update data in the lung cancer treatment group (including updated data for the 3mg/kg dose group) at WCLC, report phase 1 updated data for some bowel cancer combination treatment groups at ESMO, orally report key clinical data on treatment of NSCLC with fluzelosene tablets (KRAS G12C inhibitors) at WCLC, and phase 1 data for treating HER2-positive solid tumors with IBI354 (HER2 ADC) at ESMO, and Dabershu? (Cindilizumab Injection) Multiple Clinical Data.

Profit forecasting and investment advice. The company's revenue for 2024-2026 is estimated to be 7.9, 10.34, and 13.24 billion yuan, respectively. The company has outstanding R&D capabilities and proven commercialization capabilities. Major products such as Maxidu peptides are ready to go ahead and maintain a “buy” rating.

Risk warning: R&D progress in the research pipeline falls short of expectations; overseas listing progress or falls short of expectations; risk that future products will not be covered by health insurance.

The translation is provided by third-party software.


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