Contradictions Between FDA and Hengrui Pharmaceuticals: Behind the Launch of a New Paclitaxel Drug, a Sales Puzzle of 4.3 Billion RMB

Recently, Hengrui Medicine officially received a notice from the U.S. Food and Drug Administration (FDA) confirming that its abbreviated New Drug Application (ANDA) for paclitaxel for injection (albumin-binding) has been approved. This milestone marks Hengrui becoming the first pharmaceutical company to successfully obtain generic approval for this product in the United States.

According to the statistics of Yaozhi data, since Hengrui Pharmaceutical launched paclitaxel for injection (albumin binding type) in China in 2018, the cumulative sales of the product in domestic public medical institutions has reached 4.334 billion yuan, of which in 2021 it broke the mark of 1 billion yuan. The listing in the United States not only further promoted Hengrui Pharmaceutical's internationalization strategy, but also laid a solid foundation for the company's expansion in the global market, and significantly enhanced the company's international competitiveness and brand image.

According to the official channels of Hengrui Medicine, the injectable paclitaxel (albumin-binding type) was approved for sale in China in 2018, mainly for the treatment of metastatic breast cancer that failed combined chemotherapy or breast cancer patients who relapsed within 6 months after adjuvant chemotherapy. In 2024, the product received approval for a second indication, in combination with gemcitabine as a first-line treatment for metastatic pancreatic cancer.

In the international market, the product has also performed well and is currently approved in 15 European countries for adult patients with metastatic breast cancer who have failed first-line treatment and are not treated with standard anthracyclines, for adult patients with metastatic adenocarcinoma in combination with gemcitabine, and for adult patients with non-small cell lung cancer in combination with carboplatin.

Paclitaxel for injection (albumin-bound), as an anti-microtubule drug, has been widely used in many countries and regions since it was first approved in the United States in 2005. According to statistics, the global sales of this variety in 2023 reached about 2.597 billion US dollars.

Hengrui Pharmaceutical continues to make efforts in the process of internationalization, so far, its products have entered more than 40 countries, and in Europe, the United States and Japan and other places to obtain more than 20 registration approvals, including injections, oral preparations and inhalation anesthetics. In particular, since 2024, Hengrai has successfully approved three first imitators in the United States: paclitaxel for injection (albumin-bound), tachlimus sustained-release capsules and bupivacaine liposome injection. Among them, bupivacaine liposome injection is the first imitation drug of this variety in the world.

Tacrolimus sustained-release capsule is an important drug to prevent graft rejection after adult kidney transplantation. Its sustained-release capsule dosage form was approved by the US FDA and recognized as the first imitation drug of this variety, and it is also the first imitation product in China. The product was approved for sale in China in June 2022.

Bupivacaine liposome injection is another important breakthrough in the field of long-acting sustained-release preparations. The product was first approved for listing in the United States in 2011, but due to high technical barriers, no imitation products have been successfully listed for more than 10 years. With its unique DepoFoam technology, Hengrui Pharmaceutical successfully brought the product to market and achieved the first imitation on the market worldwide. The product has been approved for market in China at the end of 2022 and is regarded as the first ultra-long-acting local anesthetic in China through consistency evaluation.