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复宏汉霖(02696):“中国籍”单抗生物类似药在美获批并不简单,期待汉曲优市占率进一步提升

Fu Hong Han Lin (02696): It is not easy for “Chinese” single antibiotics to be approved in the US. We expect Han Quyou's market share to increase further

Zhitong Finance ·  May 16 19:28

Fu Hong Han Lin (02696): Looking forward to a further increase in Han Quyou's market share.

After achieving full year profits for the first time and successfully completing the transition to an international Biopharma, Fu Hong Hanlin (02696), which has increased by more than 30% this year, seems to be still making great strides in consolidating fundamentals...

For example, on April 26, 2024, Hanquyou (HLX02), a trastuzumab biosimilar drug for HER2+ breast cancer and gastric cancer, was approved by the FDA for marketing after being approved for marketing by the European Commission and China's National Drug Administration, making it the first “Chinese” single antibiotic similar drug approved for marketing in China, the European Union, and the US. This has undoubtedly demonstrated China's outstanding R&D strength and innovation ability in the field of biomedicine.

Han Qu Youneng obtained approval for listing from the FDA. Huang Wei, president of Fu Hong Hanlin, bluntly stated to the Zhitong Finance App at a media conference that the process was not easy. “Han Quyou's approval process in the US includes three stages: submission of BLA, on-site inspection, and approval. Don't worry, there are only three stages, but it took nearly 10 years to prepare before and after starting the R&D project. In particular, in the last 6 months of the FDA on-site inspection, Fu Hong Hanlin's entire team prepared 1,637 copies of PPT's professional English terminology materials for related technical issues only, and self-simulated them over and over again in advance so that the prosecutor could inquire.”

However, in addition to representing China's strength in the biomedical field, Han Quyou's sales performance after going public can be described as impressive. Financial reports show that in 2022, Han Quyou achieved sales of nearly 2 billion yuan, growing to 2.74 billion yuan by 2023.

Of course, when evaluating the market, the secondary market will inevitably compare it to the original research drug Roche's Herceptin. After all, since its launch in 1998, Herceptin's sales have remained stable at a high level of more than 5 billion US dollars for many years. In 2021, Herceptin's sales in the Chinese market reached 1.76 billion yuan, and its market share has remained at the forefront.

However, with health insurance coverage, Han Quyou began to challenge its market position. According to PDB data, in the first three quarters of 2023, Han Quyou relied on excellent quality and pharmaceutical policies, and its sales share in sample hospitals across the country jumped to 58.29%, successfully surpassing Herceptin and becoming a new leader in the market.

In the first quarter of 2024, despite the impact of external factors such as the Spring Festival, Han Quyou showed strong market potential and competitive strength, achieving sales of up to 670 million yuan.

Wang Yan, secretary of the board of directors of Fu Hong Hanlin and deputy general manager of public communications, pointed out that this achievement was mainly due to the firm foundation of the company's commercial team construction and precise implementation of the strategic layout.

“Take Han Quyou as an example. In the domestic market, there are relatively few companies that have set up breast cancer teams. This allows our Han Quyou team to stand out with their outstanding performance and successfully shape a good brand image. At the same time, as our business continues to expand, we have continuously introduced more products related to breast cancer, further enriching our product pipeline and adding more competitiveness to the Han Quyou Special Team. It is expected that Han Quyou's market share will continue to grow in the future.” she added.

In fact, in addition to the precise implementation of the commercialization team, Han Quyou's adoption of a differentiated competitive strategy is clearly also a means of maintaining a high market share.

The Zhitong Finance App observed that compared to Hercetin in the same 440 mg dosage form in the Chinese market and contains preservatives in the international market, Han Quyou is closer to the actual needs of Chinese patients. Since the dosage of Herceptin is closely related to the patient's body weight, and breast cancer patients, which is one of its main indications, have a large difference in body weight. Based on a 60 kg breast cancer patient, the required dose is 360 mg, which means that using the 440 mg dosage form of Hercetin will cause a certain amount of waste. Therefore, Han Quyou's differentiated design in this area has undoubtedly given it more competitive advantage in the market.

The translation is provided by third-party software.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.
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