Qilu Pharmaceutical's Trastuzumab Biosimilar Antruzhuo Approved as the Fifth Domestic Product in China
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently, Qilu Pharmaceutical Co., Ltd. announced that its trastuzumab biosimilar (trade name:Enhertu has been approved by the National Medical Products Administration (NMPA) for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
Human Epidermal Growth Factor Receptor 2 (HER2) is a transmembrane tyrosine kinase receptor present on the surface of tumor cells. Approximately 20-30% of breast cancer patients and about 15% of gastric cancer patients exhibit HER2 gene amplification and overexpression. According to statistics, there were approximately 310,000 new cases of breast cancer in China in 2016, and 400,000 new cases of gastric cancer. Currently, trastuzumab has become one of the standard treatments for HER2-positive breast and gastric cancer patients.
It is reported that Trastuzumab, the original research drug developed by Roche, is a humanized monoclonal antibody targeting HER2. It is also one of the "three mainstays" of Roche's oncology products. This product is currently internationallyMedicineThe standard treatment for HER2-positive breast cancer and gastric cancer, unanimously recommended worldwide, was approved in the U.S. in 1998 under the brand name Herceptin. In 2002, trastuzumab was approved for entry into the Chinese market. However, with the expiration of its patent and the approval of biosimilar products, Herceptin’s market share has been eroded, leading to a year-on-year decline in sales. According to Roche's financial report, global sales performance of trastuzumab in 2023 was 1.626 billion Swiss francs, representing a 16% year-on-year decrease.
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. Its 60mg specification was also approved in August 2021. In February 2023, the trastuzumab for injection from Hisun Biopharmaceutical, a wholly-owned subsidiary of Bright Future Biologics, was approved for marketing, becoming the second domestically produced product. In July 2023 and October 2023, the trastuzumab products from Zhengda Tianqing and Anke Biotechnology were successively approved for marketing.
According to Qilu Pharmaceutical, in September 2019, the company initiated a Phase I clinical study of Anqutuo. The results showed that Anqutuo is bioequivalent to Herceptin. In April 2020, a Phase III clinical study was launched. The Phase III study of Anqutuo was a multicenter, randomized, double-blind, parallel-controlled trial comparing the efficacy and safety of Anqutuo versus Herceptin, both in combination with docetaxel, in previously untreated patients with HER2-positive metastatic breast cancer. Conducted across 73 centers in China, the study met its predefined primary endpoint, showing that Anqutuo is similar to the originator drug in terms of efficacy, safety, and pharmacokinetics.
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