Incident: On October 11, the official website of the National Drug Administration (NMPA) revealed that Junshi Biotech has approved the marketing application for the recombinant humanized anti-PCSK9 monoclonal antibody angorizimab injection (JS002, trade name: Junshida). It is indicated for adult patients with essential hypercholesterolemia (non-familial) and mixed dyslipidemia who are treated with statins or with statins and ezetimib on the basis of diet control and are still unable to achieve low density lipoprotein cholesterol (LDLC) goals after receiving moderate or higher doses of statins.

Comment:

1) Angorizumab is easy and safe to administer on both administration devices, which not only simplifies the administration process, but also significantly reduces LDL-C by subcutaneous injection. The approval was based on two key registered clinical trials. The results of the JS002-003 study showed that angerizumab 150 mg subcutaneously every 2 weeks (Q2W) can significantly reduce low-density lipoprotein cholesterol (LDL-C) levels by 67.4%, maintain a steady decline during 52 weeks of treatment, and also have a significant effect on other blood lipid parameters. JS002-006 data showed that under both modes of administration (prefilled syringe (PFS) subcutaneous injection and prefilled autoinjector (AI) subcutaneous injection), angorizumab showed significant lipid-lowering effects. Compared with placebo, when patients were treated with angorizimab every 2 weeks (Q2W) for 12 weeks, their LDL-C levels decreased significantly by more than 70% on average (72.7% in the PFS group, 71.1% in the AI group), and the safety was good.

2) Angorizimab is the third PCSK9 monoclonal antibody produced in China, providing patients with new options for lipid-lowering treatment. Currently, there are 6 types of PCSK9 inhibitors approved for marketing in China: iloimab developed by Amgen (monoclonal antibody approved for marketing domestically in 2018/2 weeks); aliciumab (monoclonal antibody/approved for domestic marketing in 2019/2 weekly dosing); Inxlan developed by Novartis (siRNA/approved for domestic marketing in August 2023/8 2023/1 administration for the maintenance period every 6 months); tolecimab developed by Innova (once every 6 months) Monoclonal Antibody/2023/8 Approved for domestic marketing/including 150 mg Q2W, 450 mg Q4W, and 600 mg Q6W); inucimab developed by Kangfang Biotech (monoclonal antibody, approved for marketing in September 2024/once every 6 weeks); angorizimab developed by Junshi Biotech (monoclonal antibody/approved for marketing in October 2024/150 mg once every 2 weeks, 300 mg once every 4 weeks).

3) In the future, I am optimistic about the expansion of PCSK9 inhibitors in the domestic market and that angorizumab is expected to occupy a certain market share, becoming the company's second major product. The prevalence of hypercholesterolemia in China increased from 69.8 million in 2014 to 82.6 million in 2018, and is expected to reach 116.7 million in 2030. As a novel lipid-lowering drug that effectively reduces LDL-C levels, PCSK9 inhibitors have been recommended by domestic and foreign blood lipid management guidelines and widely recognized by clinicians. China's PCSK9 market is expected to grow further to $1.3 billion by 2030. Angorizumab is expected to occupy a certain market share, benefit from competition, and become the company's second major innovative drug after trepril.

Profit forecast: We expect the company's revenue for 2024-2026 to be 1.7, 3.2, and 4.25 billion yuan, respectively, with year-on-year growth rates of 13.14%, 88.24%, and 32.81%, respectively, and net profit to mother of -1.842, 0.041, and 0.805 billion yuan, respectively. The year-on-year growth rates are 19.34%, 102.21%, and 1880.69%, respectively, maintaining the “Highly Recommended” rating.

Risk warning: risk of clinical failure, risk of increased competition, risk of product sales falling short of expectations, policy

risk.