Over RMB 7.5 Billion Breast Cancer Drug Market Welcomes Another Entrant: Anke Biotechnology Files IPO Prospectus

　　【Pharmaceutical Network Industry DynamicsBreast cancer is one of the major malignant tumors threatening women's health, with nearly 420,000 confirmed cases of breast cancer in China in 2020. Among them, HER2-positive breast cancer has a higher degree of malignancy, faster disease progression, and is more prone to metastasis and recurrence, making it a key and challenging focus in clinical treatment. Trastuzumab, as the core representative drug for HER2-targeted therapy, is now seeing increased development and investment from numerous pharmaceutical companies.
 

On July 5, 2024, the website of the National Medical Products Administration (NMPA) announced the approval of Qilu Pharmaceutical's trastuzumab for injection (trade name: Antutu®) for marketing. It is suitable for patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer. The approval of this product marks another biosimilar that will enter clinical use by Qilu Pharmaceutical, providing new treatment options for patients in China.
 

Public information shows that the original research drug of Trastuzumab is Roche's Herceptin, which was approved for marketing in the United States on September 25, 1998, and has brought more than 100 billion US dollars in sales revenue to Roche. In September 2002, Herceptin was approved to enter the Chinese market and was included in the national medical insurance directory through medical insurance negotiations in 2017. However, as it expired, Herceptin's sales gradually declined and were impacted by biosimilars.
 

In August 2020, the first domestically produced trastuzumab (brand name: Hanshu You) independently developed and manufactured by Henlius was simultaneously launched in China and the EU. Subsequently, in March 2023, the trastuzumab for injection developed by Hisun Biologics was approved for marketing, becoming another competitor to Roche.
 

According to relevant data, the sales of trastuzumab in China's three major terminals and six major markets exceeded 7 billion yuan in 2021, and further grew in 2022, with sales surpassing 7.5 billion yuan.
 

Currently, in China, besides Qilu Pharmaceutical, several other pharmaceutical companies such as Anke Biotechnology, Chia Tai Tianqing, Henlius, Hisun Biologics, and Roche also hold production licenses for injectable trastuzumab.
 

China has a large number of breast cancer patients, leading to significant treatment demand, and some pharmaceutical companies have already reaped the benefits. For instance, in its 2022 annual report, Henlius mentioned that Hanquyou (Trastuzumab for Injection) generated revenue of approximately 1.694 billion yuan, representing a year-on-year increase of 95.2%. The 2023 annual report revealed that eight indications for six innovative drugs were approved for marketing, with key innovative products, including Hanquyou, maintaining rapid revenue growth. Notably, Hanquyou's revenue exceeded 2.7 billion yuan, marking a year-on-year increase of 58.19%. In 2023, Henlius also became one of the biopharmaceutical companies listed under Hong Kong Stock Exchange’s Chapter 18A to achieve profitability through the commercialization of innovative drugs.
 

It is foreseeable that, with more pharmaceutical companies entering the market, competition for this product will become increasingly fierce, potentially leading to a further drop in product prices.
 

Recently, Anke Bio replied to investors on an interactive platform that the end-user price of the company's Trastuzumab for Injection "Ansetin" is 1575 yuan per vial, and the current production capacity is sufficient.
 

It is reported that Ankang Biotechnology once stated that looking forward to 2024, trastuzumab provides a new growth point for profit and revenue. The company said that since the beginning of 2022, it has gradually established and improved the oncology division team, and successively carried out academic promotion and other related work to lay out the market development of anti-cancer drugs including Ansetin. Ankang Biotechnology has high hopes for this product and also hopes that it will contribute profits as soon as possible. At present, the market stock space of this product is very large, the market competition pattern has not yet formed, and the company is full of confidence in its future development.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for any person.