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和黄医药(00013.HK)港股公司首次覆盖报告:深度聚焦肿瘤小分子赛道 进入全球市场收获期

Hewong Pharmaceutical (00013.HK) Hong Kong Stock Company's First Coverage Report: Deeply Focusing on the Small Tumor Molecule Circuit Entering the Global Market Harvest Period

開源證券 ·  Jun 13

The company focuses deeply on the small tumor molecule circuit. Major international pharmaceutical companies help open up the global market. Huang Pharmaceutical is one of the first batch of new drug research and development companies in China to lay out the global market, and has achieved listing in the “three regions” of China, the US, and Europe. The company has three marketed products, including fruquintinib, sevotinib, and surufatinib, all of which have been included in the national medical insurance drug catalogue. The company has successively established strategic partnerships with major international pharmaceutical companies such as AstraZeneca, Eli Lilly, and Takeda Pharmaceuticals in order to better position the global market quickly. Among them, fruquintinib was approved for marketing in the US in 2023, and Takeda Pharmaceuticals is responsible for commercial sales in overseas markets. In the next few years, the company will have multiple product pipelines with multiple indications, which are expected to gradually be approved in the global market, and the company has already entered the global harvest period. We are optimistic about the long-term development of the company. Based on the pipeline that has been approved and is expected to be approved soon, the peak pipeline sales volume is 24.061 billion yuan, and the company's corresponding equity share is 8.749 billion yuan. The company's net profit for 2024-2026 is estimated to be -648/0.18/1,131 million yuan, and PS is 4.84/3.65/2.94X, respectively, covered for the first time, giving it a “buy” rating.

Fruquintinib first opened up the US market. Fruquintinib entered the global harvest period. Fruquintinib's third-line treatment for colorectal cancer has been approved in China, and has strongly occupied the Chinese market with its efficacy advantages; marketing applications for gastric cancer and endometrial cancer with combination chemotherapy or immunotherapy were also accepted by CDE in 2023 and 2024, respectively; since approval for marketing by the FDA in November 2023, fruquintinib has been rapidly released in the US market, and the company has simultaneously submitted marketing applications in Europe and Japan, and fruquintinib has entered the global harvest period. Sevotinib was approved for second-line treatment of patients with MET mutation NSCLC in 2021, and is the first MET inhibitor approved in China; the first-line treatment plan was accepted by the CDE in 2024; NDA applications for EGFR TKI-resistant NSCLC patients with osimitinib are expected to be submitted to the FDA and CDE in 2024 and 2025, respectively. Sevotinib may become the company's second drug approved overseas.

The company has a comprehensive layout for hematomas. Self-exempt drug marketing applications have been accepted by CDE. The company fully covers hematologic tumor subtypes, and the hematoma pipeline is about to enter an intensive approval period. Among them, the marketing application for the Syk inhibitor zolepinib was accepted by the CDE in January 2024, making it the first Syk inhibitor to be declared for marketing in China. The EZH2 inhibitor tazepastat will be rapidly declared for marketing through bridging tests. HMPL-306 has initiated a registered phase III clinical trial for relapsed/refractory acute myeloid leukemia.

Risk warning: Drug clinical development failure, drug safety risks, loss of core members, deterioration of the industry competition pattern, etc.

The translation is provided by third-party software.


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