occurrences
Recently, the board of directors of the company elected Mr. NING LI (Li Ning) as the vice chairman of the third board of directors of the company. Mr. NING LI (Li Ning) will be appointed as the chairman of Topu Ailai Biotechnology Co., Ltd., a wholly-owned subsidiary of the company, to be responsible for the company's overseas business; the company's board of directors agreed to appoint Ms. Zou Jianjun as the company's general manager and CEO to preside over the overall work of the company.
Comment:
A new general manager/CEO has taken office, has extensive experience in R&D and management, and is expected to bring about positive changes. Zou Jianjun was hired as the new general manager/CEO. She has many years of R&D experience in well-known pharmaceutical companies. She has served as the head of global medical affairs at Bayer, the head of Chinese medical affairs at Xinji Pharmaceuticals, and the chief medical officer of Hengrui Pharmaceuticals, and was the Deputy General Manager and Global R&D President of Junshi Biotech from April 2022 to January 2024. She will preside over the overall work of the company to enhance the company's competitiveness and influence in many aspects.
The company's R&D side ushered in many positive developments, and the pipeline continued to advance. After Zou Jianjun was responsible for the company's R&D work, the company's R&D side ushered in many positive changes: core product development? More than 40 clinical studies with more than 15 cancer indications have been carried out globally. Currently, 7 indications have been approved domestically, and 6 indications have been included in the medical insurance catalogue. At the same time, 3 NDAs for new indications have been accepted by the NMPA, and it is expected that 10+ domestic indications will be approved in the future. Overseas, treprilizumab has been successfully approved for marketing by the FDA, achieved the milestone of domestically produced innovative drugs, and has accumulated external licensing in more than 50 countries. It is expected that it will continue to reap milestones and sales shares. The international multi-center phase III clinical study of anti-BTLA monoclonal antibody (Tifcemalimab) for the treatment of limited-stage small cell lung cancer has completed the world's first patient enrollment and first administration (the first in the world); the phase III clinical study for the treatment of classic Hodgkin lymphoma has officially started. It is expected that the company's R&D pipeline will continue to make positive progress.
Focus on the company's recent multilateral catalysts and performance-side improvements. Treprizumab is expected to be approved for triple-negative breast cancer and first-line kidney cancer in H1 in 2024. If approved, it will be the first domestically produced PD-1 monoclonal drug approved for this indication. As 3 first-line indications are included in the new medical insurance catalogue (implementation began in January) and subsequent multiple indications continue to be approved, it is expected that the domestic Tuoyi sales performance side will continue to improve.
At the same time, relevant marketing applications submitted by treprilizumab in the UK, the European Union and Australia have been accepted, and it is expected that it will continue to expand overseas markets and realize the value of the product.
Profit forecast and valuation: The company focuses on the development of innovative drugs in the field of oncology, etc., with promising potential. It is expected to achieve revenue of 13.90/18.47/2,840 billion yuan in 2023-2025, with earnings per share -1.97/-1.13/-0.28 yuan/share, maintaining a “buy” rating.
Risk warning: R&D pipeline progress falls short of expected risks, commercialization falls short of expected risks, etc.