October 27, 2025, Guangzhou, China

Meiji Biopharmaceutical (Guangzhou) Co., Ltd. announced that its self-developed oral paclitaxel soft capsule (project code: MJC-001) officially received the Notice of Approval for Drug Clinical Trial (approval number: 2025LP02805) from the National Medical Products Administration (NMPA) of China yesterday (October 26), agreeing to conduct clinical trials.

This marks another significant milestone following the "zero-defect" approval of MJC-001 by the US FDA for clinical trials in early 2025, indicating that the world's first oral paclitaxel soft capsule project is about to enter the clinical development stage in China.

Breaking through the limitations of traditional dosage forms and solving the problem of oral administration of paclitaxel.

Paclitaxel is a cornerstone drug in cancer chemotherapy. Over the past 50 years, due to technical challenges such as poor water solubility and low bioavailability, it has been limited to intravenous administration. Patients need to frequently visit hospitals and undergo hours of infusion, often accompanied by side effects such as allergic reactions and peripheral neurotoxicity.

Dr. Huang Huiyu, founder and chief scientific officer of Meiji Pharmaceutical, said, "MJC-001 is the first and only orally administered paclitaxel soft capsule project approved for clinical trials globally. We have successfully overcome the pharmaceutical bottlenecks of poor solubility, low gastrointestinal permeability, and strong first-pass effect of paclitaxel by adopting innovative liposomal nanomedicine delivery technology.". ”

Preclinical research data indicate that oral paclitaxel soft capsules exhibit excellent efficacy and safety in various tumor models, with efficacy superior to/non-inferior to mainstream paclitaxel drugs already on the market (such as Abraxane® and traditional paclitaxel Taxol®). The tumor inhibition rate is up to nearly 100%, and the tumor volume shrinks by 3-6 times after three weeks of treatment.

The differentiated advantage is evident, and the clinical application prospect is vast

Compared to injectable paclitaxel, oral paclitaxel soft capsules offer multiple advantages:

High patient compliance: Oral administration is convenient, which can significantly reduce hospitalization time and medical resource utilization, thereby lowering healthcare costs.

Improved safety: Preclinical studies have shown a significant reduction in toxic side effects, which can prevent allergic reactions associated with intravenous administration.

Potential for indication expansion: It has demonstrated good therapeutic effects in preclinical studies for indications such as gastric cancer and liver cancer, and is expected to expand beyond the scope of traditional paclitaxel injections.

Future development plan and strategic layout

With the approval of clinical trials by the NMPA, Meiji Pharmaceutical will accelerate the clinical development process of oral paclitaxel soft capsules in China. The company plans to initiate phase I clinical trials as soon as possible and explore ways to accelerate drug development through the fast-track review process.

In addition to the common solid tumor indications of paclitaxel, such as lung cancer, breast cancer, and ovarian cancer, the company will also explore its potential applications in areas such as gastrointestinal tumors and autoimmune diseases. In the future, oral paclitaxel is expected to be used in combination with immunotherapy drugs or targeted drugs, opening up new treatment options for cancer.

Meiji Pharmaceutical and its partner Medix have jointly overcome a series of technical challenges including formulation development, efficacy evaluation, pharmacokinetics, and safety evaluation. Medix, leveraging its extensive preclinical research and development experience, provided one-stop technical support for this project.

About Meiji Pharmaceutical

Based on its globally leading drug delivery technology platform, Meiji Biopharma (Guangzhou) Co., Ltd. is committed to providing cost-effective solutions for unmet clinical medical needs. The core members of the company have participated in the development of blockbuster drugs for multinational pharmaceutical companies such as Novo Nordisk and Novartis, and have been involved in the industrialization of products worth over $4 billion. Currently, Meiji Biopharma has established a diversified pipeline including oral paclitaxel, water-based propofol, and oral GLP-1 drugs.