Shanghai Haihe Biopharma Co., Ltd, a partner of 3SBio Inc. (HKG: 1530), announced that its paclitaxel oral solution (registered trademark: Liporaxel; development code: RMX3001/DHP107), developed in collaboration with South Korea‑based Daehwa Pharmaceutical, has received approval from the National Medical Products Administration (NMPA) for a new indication in the treatment of recurrent or metastatic HER2‑negative breast cancer.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | New indication for existing product |
| Product | Liporaxel (paclitaxel oral solution; RMX3001/DHP107) |
| New Indication | Recurrent or metastatic HER2‑negative breast cancer |
| Prior Indication | Advanced gastric cancer post first‑line fluorouracil‑based regimens (approved Sep 2024) |
| Approval Date | 10 Oct 2026 |
| Reimbursement Status | Included in the National Reimbursement Drug List (NRDL) in 2025 |
Drug Profile & Mechanism of Action
- Molecule: Paclitaxel — a widely used taxane‑class chemotherapeutic agent that stabilizes microtubules, inhibiting cell division and inducing apoptosis in rapidly proliferating cancer cells.
- Formulation Innovation: Liporaxel is the world’s first and only orally administered paclitaxel product, converting a drug historically available only as an intravenous injection into a patient‑friendly oral dosage form.
- Development Partner: Originally developed by Daehwa Pharmaceutical (South Korea); Haihe Biopharma holds the development, manufacturing, and marketing rights in China and Thailand (licensed Sep 2017).
- Commercialization Partner: 3SBio Inc. obtained exclusive commercialization rights for Liporaxel in mainland China and Hong Kong from Haihe in October 2024.
Clinical Evidence – Phase III OPTIMAL Study (107CS‑5)
| Endpoint | Result (Liporaxel Oral) | Comparator (Paclitaxel Injection) | Outcome |
|---|---|---|---|
| Primary Endpoint – PFS | Non‑inferior | Standard IV paclitaxel | Non‑inferiority met |
| Patient Population | Recurrent or metastatic HER2‑negative breast cancer | – | – |
| Safety Profile | Not disclosed in detail | – | Consistent with known paclitaxel profile |
The OPTIMAL study (NCT03315364; CTR20190448) is a global, pivotal Phase III registration trial designed to evaluate the efficacy and safety of Liporaxel oral solution versus conventional paclitaxel injection in patients with recurrent or metastatic HER2‑negative breast cancer. The study successfully met its primary endpoint of progression‑free survival (PFS) non‑inferiority, supporting the regulatory submission and subsequent NMPA approval.
Market Impact & Outlook
- Breast Cancer Landscape in China: Breast cancer is the most commonly diagnosed malignancy among Chinese women, with HER2‑negative subtypes accounting for the majority of cases. The availability of an oral taxane option addresses a significant patient need for convenient, outpatient‑friendly chemotherapy.
- Oral vs. Injectable Advantage: Conventional paclitaxel requires intravenous infusion with premedication for hypersensitivity prophylaxis, typically administered in a hospital or infusion center. Liporaxel’s oral formulation has the potential to reduce healthcare resource utilization, improve patient quality of life, and enable broader access in community and outpatient settings.
- Portfolio Expansion: With the new breast cancer indication, Liporaxel now carries two NMPA‑approved indications (advanced gastric cancer and HER2‑negative breast cancer) and is already reimbursed under the NRDL, positioning it for accelerated commercial uptake through 3SBio’s established oncology sales infrastructure.
- Strategic Value for 3SBio: The approval strengthens 3SBio’s oncology portfolio and validates its Oct 2024 exclusive licensing deal with Haihe, which secured commercialization rights just over one year before this second indication was approved.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercial outlook for Liporaxel in China, including its potential market penetration in the breast cancer indication, the impact of NRDL inclusion, and the strategic partnership between Haihe Biopharma, 3SBio, and Daehwa Pharmaceutical. Actual results may differ due to risks including competitive dynamics, reimbursement policy changes, post‑marketing safety findings, and regulatory developments in other jurisdictions.-Fineline Info & Tech
