On June 15, 2026, the injectable paclitaxel (albumin-bound) (II) (R&D code: SYHX2011) developed by CSPC Ouyi Pharmaceutical Co., Ltd. was approved for marketing by the National Medical Products Administration. This product is the world’s first instant-release albumin-bound paclitaxel formulation, relying on independently innovated formulas and preparation processes, and has obtained patent authorizations from multiple countries including China, the United States, and Europe. As an improved new drug of chemical drug category 2.2, it achieves comprehensive upgrades in efficacy, safety, and clinical convenience, filling multiple clinical shortcomings of traditional albumin-bound paclitaxel. It marks a technological breakthrough for CSPC Pharmaceutical Group in the field of anti-tumor nano-formulations and brings a new, higher-quality chemotherapy option for patients with advanced breast cancer.

SYHX2011 has undergone systematic optimization of the formulation. Without altering the effective drug dose, it significantly reduces the content of excipients such as human albumin and sodium caprylate, removes allergenic impurities, and optimizes the nanostructure, enhancing the tumor tissue targeting and accumulation ability as well as stability. Leveraging the tumor EPR effect, it strengthens the anti-tumor effect. The multi-center, randomized, double-blind Phase III trial supporting this approval enrolled a total of 459 patients with locally advanced and metastatic breast cancer. In terms of safety, the incidence of rash decreased by 26.4%, the rate of drug withdrawal due to adverse events significantly decreased, and the median dosing period and cumulative dose of the drug were simultaneously increased. Clinically, this product is a rapid-dissolution formulation, reducing the preparation time by 82%, significantly improving the efficiency of diagnosis and treatment in hospitals.

Breast cancer is a highly prevalent malignant tumor. According to a report from the National Cancer Center of China, there were approximately 376,000 new cases of breast cancer in China in 2024. The overall 5-year survival rate for patients with advanced breast cancer is only around 20%, indicating a significant disease burden. The indication approved this time is for metastatic breast cancer that has failed combination chemotherapy or recurred within 6 months of adjuvant chemotherapy. Most of these patients have previously received anthracycline-based treatment, leaving limited options for subsequent treatment.

Currently, there are two categories of paclitaxel-based anticancer drugs listed on the China Drug Patent Information Registration Platform: paclitaxel injection and paclitaxel liposome for injection, both of which are chemical drugs. The paclitaxel injection is an injection preparation and a Class A national medical insurance drug, with a specification of 5ml:30mg. Its marketing authorization holder is Jiangsu Jiuxu Pharmaceutical Co., Ltd., and it has two registered patents: 201310676256.X(expiration date: December 11, 2033) and 201711387381.3(expiration date: December 20, 2037). The reference indications for paclitaxel injection include adjuvant therapy for breast cancer patients with positive lymph nodes after standard chemotherapy regimens containing doxorubicin; breast cancer patients with metastatic disease who have failed to respond to adjuvant chemotherapy or have relapsed within 6 months of adjuvant chemotherapy; first-line treatment for non-small cell lung cancer patients; and second-line treatment for AIDS-related Kaposi’s sarcoma, among others. The paclitaxel liposome for injection is a targeted agent, with a specification of 30mg. Its marketing authorization holder is Nanjing Luye Pharmaceutical Co., Ltd., and it has two registered patents: 00119039.3 (expired and expired on October 18, 2020) and 202010388812.3 (expiration date: May 8, 2040). The reference indications for paclitaxel liposome for injection include: it can be used for first-line chemotherapy of ovarian cancer and subsequent treatment of ovarian metastatic cancer; as first-line chemotherapy, this product can also be used in combination with cisplatin; it can also be used f for subsequent treatment of breast cancer patients who have previously received doxorubicin-containing standard chemotherapy, or for the treatment of relapsed patients; and it can be used in combination with cisplatin for first-line chemotherapy of non-small cell lung cancer patients who are inoperable or unable to undergo radiotherapy.

In the breast cancer chemotherapy arena, traditional chemotherapeutic drugs, targeted drugs, and immunotherapeutic drugs have formed a combined system. This upgraded paclitaxel preparation can be flexibly combined with various drugs, offering a wide range of applicable scenarios and demonstrating outstanding market competitiveness.

References:

1. https://mp.weixin.qq.com/s/5o1Vlftzi0X6kG3seamkqg

2. https://db.yaozh.com/pijian/bJmWaWllbGVnlWRilJaUlzkwMzli.html

3. https://db.yaozh.com/pijian/bJmWaWlla2dnlWRilJaYljkwMzli.html