In prostate cancer diagnosis and treatment, more and more attention is being paid to full management, with the aim of extending the survival benefits of patients.
The Zhitong Finance App learned that according to a research report released by Ping An Securities, prostate cancer is commonly known as “retirement cancer,” and the incidence rate in China continues to rise as the population ages. Prostate cancer has a low tumor mutation burden and cold tumor properties, etc., and immunotherapy is generally effective against mCRPC. In prostate cancer diagnosis and treatment, more and more attention is being paid to full management, with the aim of extending the survival benefits of patients. The application of second-generation AR antagonists showed clinical improvement at various stages of prostate cancer progression (MHSPc, nmCRPC, mCRPC). Based on the novel endocrine therapy, the company's innovation point is to further extend patient OS by solving drug resistance/reducing toxicity/precise treatment/combination medication. It is recommended to focus on setting up PSMA RLT companies.
In 2022, the number of new cases of prostate cancer in China exceeded 0.13 million. The majority of first-time patients in China were in the middle to advanced stages, and the overall prognosis was relatively poor. Prostate cancer is one of the common malignant tumors in middle-aged and elderly men, and is also known as “retirement cancer.” In recent years, the incidence and death rate of prostate cancer in China has increased year by year. According to data from the China Cancer Registration Center, the domestic prostate cancer incidence rate increased from 0.102/0.1 million to 0.186/0.1 million from 2015 to 2022, and the number of new cases in China exceeded 0.13 million in 2022. Prostate cancer patients in China have a high metastasis rate, accounting for more than 50% of first-time patients, and the overall prognosis is relatively poor. Domestic prostate cancer patients have a 5-year survival rate of 60% +. Compared with the 5-year survival rate of over 90% in the US and Japan, there is still a gap in the survival benefits of patients.
Hormone therapy is the standard first-line treatment for advanced prostate cancer. Currently, domestic prostate cancer drugs are still mainly GnRH, and the foreign prostate drug market is dominated by second-generation AR antagonists. Most prostate cancer cells rely on testosterone to grow. Hormone therapy can shrink or slow growth of prostate cancer cells. It is a standard first-line treatment for advanced prostate cancer. Common hormonal drug classifications include gonadotropin-releasing hormone (GnRH) agonists/antagonists, CYP17 inhibitors, and first/second-generation AR antagonists. China's prostate cancer market reached 8.1 billion yuan in 2022, and is still dominated by the GnRH agonists leuprorelin and goserelin. Compared with overseas prostate cancer drugs, which are mainly second-generation AR antagonists, global sales of enzalutamide/apatamide/darotamide in 2023 were 5.723/2.387/0.93 billion US dollars, respectively, for a total of 9 billion US dollars. Domestic second-generation AR antagonists have all been covered by medical insurance. In 2023, the sales volume of the enzalutamide sample hospital reached 0.273 billion yuan, and the dosage is in its infancy.
Deuteration technology/Protac/antisense nucleic acid therapy addresses drug resistance, and precision treatment with PARP inhibitors/targeted PSMA prolongs survival benefits. Prostate cancer treatment management aims to prolong the survival benefits of patients. Follow-up innovative therapies aim to address the resistance of existing treatments, improve safety, or use biomarkers for more precise treatment. ① Targeted AR is developing different technical paths to solve the mCRPC resistance problem: deuteration technology (Haichuang Pharmaceutical's deuterium enzalutamide is expected to be approved for 3L mCRPC within 2024), Protac technology (overseas target company Arvinas; domestic proTAC layout includes Haichuang Pharmaceutical HP518, Hengrui Pharmaceutical HRS-5041, Hisco AR-V7 degraders, etc.), antonymised nucleic acid therapy, etc. ② Targeted PSMA treatment for prostate cancer is mostly RLT therapy: PSMA targets are diagnostic and treatment targets for prostate cancer stars, and are highly expressed on the surface of mCRPC cancer cells. Novartis Pluvicto was approved for 3L mCRPC in the US in March 2022. Global sales reached 0.98 billion US dollars in 2023, and continued to advance through frontline treatment. Currently, technical pathways targeting PSMA to treat prostate cancer include radioligand therapy (RLT), PSMA ADC, PSMA CART, PSMA monoclonal antibody, PSMA dual antibody, etc., of which RLT therapy is mostly used. The relevant domestic layout and progress are: Yuanda Pharmaceutical's 177 Lu-TLx591, global clinical phase 3, domestic pre-clinical phase; Xiantong Pharmaceutical's 177 Lu-EB-PSMA-617 clinical phase 1/2; Nuoyu Pharmaceutical's 177 Lu-nY108 clinical phase 1/2; crystallobiology clinical phase 1/2; and Lanna Cheng Biotech's two pipelines are in phase 1 clinical phase.
Investment advice: It is recommended to focus on the layout of PSMA RLT companies, such as Yuanda Pharmaceutical (177Lu-TLx591), Xiantong Pharmaceutical (177Lu-EB-PSMA-617), Lannacheng Biotech (Dongcheng Pharmaceutical Holdings subsidiary) and AR therapy innovation layout, such as Haichuang Pharmaceutical (deuterium enzalutamide and AR Protac HP518), Hengrui Pharmaceutical (AR Protac HRS-5041), and Hisilco (AR-V7 degrading agent).
Risk warning: policy risk; risk of R&D failure; increased risk of competition, etc.
