Shijiazhuang Pharma Group's Paclitaxel (Albumin-Bound) (II) (Xinbaizi®) Delivered Nationally for the First Time, Offering a New Treatment Option for Patients with Advanced Breast Cancer

On July 2, a vehicle carrying the first batch of CSPC’s Paclitaxel for Injection (Albumin-Bound) (II) (brand name: Xinbaizi^®) professional transport vehicles slowly drove out of the production plant of CSPC Ouyi Pharmaceutical Co., Ltd., heading to major medical institutions across China. This marks the official clinical launch of the world’s only fast-dissolving, optimally upgraded albumin-bound paclitaxel, bringing a new treatment option for patients with advanced breast cancer.

Xinbaizi^®Approved for marketing by the National Medical Products Administration (NMPA) on June 10, 2026. The indications for this product are: metastatic breast cancer after failure of combination chemotherapy, or breast cancer relapsing within 6 months after adjuvant chemotherapy. Unless contraindicated clinically, prior chemotherapy should have included an anthracycline anticancer drug. CSPC’s Paclitaxel for Injection (Albumin-Bound) (II), through its innovative patented process, achieves Xinbaizi^®The value enhancement of increased efficacy, reduced toxicity, and rapid compatibility has addressed the clinical application shortcomings of traditional albumin-bound paclitaxel, achieving an upgraded iteration of albumin-bound paclitaxel drugs.

To ensure that the product benefits patients as soon as it reaches the market, relevant departments of CSPC Pharmaceutical Group Limited have rapidly coordinated and deployed resources, with personnel systematically advancing production, quality control, marketing, and other end-to-end processes. The product will be delivered to Hebei, Beijing, Tianjin, Shandong, Shanxi, Henan, and other regions within 24 hours, and nationwide across China within 48 hours.

Paclitaxel for Injection (Albumin-Bound) (II) (Xinbaizi)^®) Classified as a chemical drug category 2.2, leveraging exclusive PCT formulation patents and ultrafiltration dialysis technology, this product reduces the human serum albumin content from 900 mg to 200 mg and the sodium caprylate content from 11 mg to 2 mg, while maintaining the paclitaxel content at 100 mg. This effectively removes allergenic impurities and significantly reduces the incidence of adverse reactions. Compared with traditional albumin-bound paclitaxel, Paclitaxel for Injection (Albumin-Bound) (II) features reduced particle fragments, enhanced nanoparticle stability, and slower disintegration rate after entering the bloodstream. It demonstrates enhanced EPR effect (enhanced permeability and retention effect) in tumor tissues and improved active transport efficiency, resulting in a significant upgrade in therapeutic efficacy.

Phase III clinical studies verified the superiority of Paclitaxel for Injection (Albumin-Bound) (II) over conventional albumin-bound paclitaxel:

Significant Improvement in Efficacy:The Independent Review Committee (IRC) assessment results showed that, compared with the control group, the Objective Response Rate (ORR) of Paclitaxel for Injection (Albumin-Bound) (II) was significantly increased by 10% (35.8% vs. 25.8%); the median Progression-Free Survival (mPFS) was significantly prolonged by 1.5 months (8.31 months vs. 6.83 months); and the risk of death was reduced by 33% (HR=0.67), demonstrating a clear survival benefit.

Enhanced Safety:The risk of rash was significantly reduced by 62% (16.2% vs. 42.6%); the rate of permanent discontinuation due to treatment-emergent adverse events (TEAEs) was substantially decreased (with neurotoxicity being the primary cause of permanent discontinuation). The improved safety profile further enhanced patient treatment tolerance; study data showed that the mean number of treatment cycles increased by 0.7, and the cumulative drug dose increased by 16.4%, thereby ensuring the successful administration of full-course, full-dose chemotherapy.

More Convenient for Clinical Use:This product features a rapid-dissolution formulation, with a median preparation time of only 1.97 minutes, representing an 82% reduction compared to traditional albumin-bound paclitaxel (median preparation time: 10.98 minutes). This effectively simplifies clinical workflows, reduces nursing workload, and enhances in-hospital diagnostic and treatment efficiency.

CSPC Deepens Its Commitment to Oncology, Breaking the Limitations of Existing Chemotherapy Drugs through Formulation Innovation: Xinbaizi^®The approval and market launch of this product not only serve as a powerful testament to the independent R&D capabilities of domestic pharmaceutical enterprises, but also inject new momentum into the standardized treatment of breast tumors. In the future, CSPC will remain committed to its corporate mission of “Making Quality Medicines for China and Benefiting People Worldwide,” deepen its engagement in the innovative drug R&D sector, continuously break through technical bottlenecks in anti-tumor therapy, strive to extend the survival periods of cancer patients, and promote the high-quality development of China’s anti-tumor medical industry.