Paclitaxel, a cornerstone drug in the field of cancer chemotherapy, has become a basic treatment for various solid tumors, including breast cancer, ovarian cancer, and lung cancer, since its clinical application in the 1990s, and still maintains a global market size of nearly ten billion US dollars. However, in contrast to its repeatedly verified efficacy, the administration method has stagnated for a long time—for more than 30 years, the clinical application of paclitaxel has still relied heavily on intravenous infusion, and the therapeutic effect has reached a plateau, making it difficult to improve further.

This drug delivery route means that patients need to make periodic trips to the hospital for treatment, while also enduring adverse events related to excipients such as allergic reactions and neurotoxicity, and consuming a significant amount of medical resources. Despite the emergence of numerous new therapies, the bottlenecks in the delivery method and user experience of this mature molecule have not yet been systematically resolved.

Guangzhou-based Meiji Biotech started from this structural contradiction, choosing to focus its R&D efforts on the delivery system itself, exploring the practical feasibility of oral paclitaxel. To this end, the company built a self-emulsifying liposome nanoparticle drug delivery (SELNP) platform, and on this basis, is advancing the development of its core product, MJC-001.

The founding of Miji Biopharma stemmed from founder Dr. Huang Huiyu's observations and reflections on the long-term operational logic of the drug development system. As a technology-driven entrepreneur with over 20 years of international experience in new drug development, he has worked for multinational pharmaceutical companies such as Novo Nordisk and Novartis, and was deeply involved in the development of several blockbuster drugs, including Semaglutide and Secukinumab, whose combined global annual sales exceed US$30 billion.

His long-term experience within multinational pharmaceutical companies gradually made him realize that R&D resources and innovative attention are often concentrated on new targets and molecules, while mature drugs that have been proven effective but have significant shortcomings in terms of administration methods, frequency of use, or patient experience typically fail to receive long-term, sustained R&D investment, and their clinical and commercial value is not widely recognized. It is worth noting that the current trend of many traditional intravenous monoclonal antibody drugs being replaced by subcutaneous injections fully reflects the clinical and commercial value of formulation innovation.

Paclitaxel is a prime example of this misconception—its efficacy has been thoroughly validated, yet it has long been assumed to be usable only by injection. Consequently, the exploration of whether paclitaxel could truly be administered orally has remained on the fringes.

In the interview, Huang Huiyu recalled that such attempts were not uncommon, and large foreign pharmaceutical companies had also invested in in-depth research and development. However, their approaches were relatively concentrated and repeatedly failed: one approach aimed to improve oral bioavailability by changing the molecular structure, but it was halted at the clinical stage due to safety issues; another approach attempted to make breakthroughs from the formulation perspective, but it was constrained by the large molecular weight of paclitaxel (about 850 Da), its classification as a Class IV drug in the Biopharmaceutics Classification System (BCS), and its multiple limitations such as low solubility, low permeability, and potential gastrointestinal toxicity.

In practice, projects from companies such as Bristol-Myers Squibb (BMS), Odonate Therapeutics, and Athenex have all encountered setbacks in the clinical stage, while some marketed products still pose a risk of blood toxicity due to their reliance on high proportions of polysorbate 80.

After systematically reviewing these experiences, Huang Huiyu founded Meiji Bio in Huangpu, Guangzhou, and made a clear choice: not to change the molecular structure of paclitaxel, but to attempt to solve the balance between stability and safety during oral administration by reconstructing the delivery system. In his view, only when oral formulations achieve comprehensive advantages in efficacy, safety, and ease of use can they truly replace existing injection regimens, rather than remaining a supplementary option.

This judgment is also reflected in the company's organizational and commercialization strategies. Migene Biopharma focuses its resources on core technologies and early clinical validation, planning to introduce partners through licensing or joint development once key data is clear, to advance later-stage development and commercialization. In terms of organizational structure, the company uses its core team as the central hub, collaborating with CROs and research institutions to advance R&D, aiming to reduce early-stage costs and improve efficiency.

The aforementioned technological and strategic path has gradually translated into clear, phased progress: In 2023, proof-of-concept for oral paclitaxel was completed and IND-enabling studies were advanced; in 2024, preliminary preparations for dual IND applications in China and the US were initiated, domestic invention patent authorization was obtained, and PCT international patent applications were filed; in 2025, the core product MJC-001 received clinical trial approvals from both the FDA IND and NMPA. Currently, the company is pursuing a Pre-A round of financing to fund the Phase I clinical trial of MJC-001 in China and the early-stage advancement of other ongoing research projects.

Miji Biopharma's ability to deliver paclitaxel orally is largely due to its self-emulsifying liposome nanoparticle (SELNP) platform. This platform does not simply increase drug loading or pursue more complex structures, but rather redesigns the absorption and distribution pathways of the drug after it enters the body, allowing the drug to reach its target site (such as tumor tissue) in a stable and controllable manner, thus achieving an effective and safe in vivo exposure.

Unlike traditional liposomes or ionic lipid nanoparticles (LNPs) that rely on pre-formed nanostructures, SELNPs form a stable, homogeneous concentrated system by combining the active pharmaceutical ingredient with screened lipid excipients. After administration, the system is diluted with body fluids, spontaneously forming nanodroplets with controllable particle size. This mechanism allows the "self-assembly" of the delivery structure to occur during in vivo drug delivery, thereby significantly increasing drug loading capacity while improving the solubility and absorption efficiency of poorly soluble drugs, cyclic peptides, polypeptides, and mRNA. Furthermore, it avoids dependence on complex equipment and processes during drug preparation and storage, significantly reducing production costs.

In terms of safety and accessibility, SELNP does not rely on potentially sensitizing excipients such as phospholipids, cholesterol, organic solvents or Tween compounds, reducing the risk of immune reactions and toxicity common in traditional lipid delivery systems. At the same time, the platform is based on a homogeneous liquid process, which does not require freeze-drying or cryogenic storage, making it practically feasible in terms of production scale-up, storage and transportation and cost control.

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Comparison of SELNP with Common Technology Platforms

More importantly, this platform is not limited to customization for single molecules. Migene Biopharma disclosed that SELNP has been validated in preclinical studies as compatible with small molecule drugs, peptides (linear and cyclic peptides), antibodies, and nucleic acid molecules, and supports multiple routes of administration, including oral, injectable, and transdermal administration. In terms of tissue distribution, it is not limited to single organs such as the liver, but can cover multiple tissues including tumors, the digestive tract, and the lungs, providing a foundation for subsequent pipeline expansion and new indications.

In terms of pipeline selection, Miji Biopharma chose paclitaxel, the most challenging drug, as the first validation target for its platform capabilities. As the company's core product, MJC-001 employs a low-dose, high-frequency rhythmic dosing regimen, attempting to improve therapeutic efficacy and reduce the toxic side effects of traditional "high-dose injections every three weeks" through more stable in vivo exposure levels, while also delaying the onset of drug resistance.

In preclinical head-to-head studies, MJC-001 has shown significant therapeutic potential, exhibiting more sustained and significant inhibition of tumor growth compared to the intravenous albumin-bound paclitaxel group over the same treatment period.

Specifically, in the MDA-MB-231 breast cancer xenograft model, the tumor inhibition rate of the 100 mg/kg oral dose group exceeded 90%; in the Hs746T gastric cancer xenograft model, the tumor inhibition rate (TGI) was the highest, approaching 100%, and the overall efficacy was better than that of the control group receiving intravenous abraxane 30 mg/kg.

Regarding safety, animal studies showed that oral administration of MJC-001 was well-tolerated. In mouse, rat, and beagle models, no significant weight loss or systemic toxicity was observed under continuous or high-dose administration. Its maximum tolerated dose was significantly higher than previous oral paclitaxel candidates and commonly used injectable formulations. Hematological, biochemical, and major organ pathological assessments were generally manageable, and the incidence of key adverse reactions such as neutropenia was lower than that of Taxol.

In terms of regulatory pathways, MJC-001 has received clinical trial approvals from the FDA and NMPA, and plans to simultaneously advance a multi-center Phase I clinical trial in China and the United States, focusing on evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy.

In addition, Meiji Bio has developed its second core pipeline, MJC-002—a water-based propofol injection. Compared to MJC-001, MJC-002 is still in an earlier stage. Propofol, a commonly used anesthetic in clinical practice and surgery, has long been formulated as a fat emulsion, which carries safety risks such as respiratory depression, injection pain, lipid overload, decreased blood pressure, and propofol infusion syndrome (PRIS). Its use is also limited in some individuals with allergies. MJC-002 utilizes SELNP technology to achieve a water-based, homogeneous, fat-free formulation. Preclinical studies have shown that it achieves comparable anesthetic effects to the original drug at lower doses, with faster recovery, lower allergy risk, and significant improvement in blood pressure reduction.

While advancing its core pipeline, Migene Biopharma is also exploring long-term R&D directions based on the clinical experience gained with MJC-001. The company envisions that the formulation, dosing, and safety data accumulated from oral paclitaxel will provide practical references for more innovative molecules in the future. In its long-term plan, Migene Biopharma aims to expand its SELNP platform to more molecular types and disease areas, including oral peptides, cyclic peptides, in vivo CAR-T, antibodies, and combination therapies for cancer.

Overview of Meiji Bio's pipeline layout

With innovative drugs continuing to receive attention, discussions about R&D efficiency and clinical certainty are gradually returning to rationality. Beyond FIC and BIC innovative drugs, R&D pathways based on mature molecules and optimized around clearly defined clinical pain points and unmet clinical needs are being re-evaluated for their clinical and industrial value. As Dr. Huang Huiyu stated in an interview, the long-term pursuit of breakthrough innovation does not mean that other forms of innovation are meaningless.

Taking improved new drugs as an example, these products rely on proven active molecules and improve safety, compliance, or user experience through optimization of dosage form, administration method, or delivery system. They are then compared with standard treatments of already marketed drugs to validate long-standing but insufficiently addressed clinical needs. This approach has mature practices both domestically and internationally. Luye Pharma's liposomal paclitaxel "Lipusu," and the overseas albumin-bound paclitaxel, have both established stable clinical application foundations and achieved considerable market returns through formulation-level innovation without altering the core mechanism of action.

From a research and development perspective, these products have a clear mechanism of action, predictable side effects, and controllable risks. They can be directly compared with existing gold standard treatments before entering the clinical trial stage, resulting in relatively clear boundaries between efficacy and safety. This not only reduces research and development uncertainty but also makes their clinical value more easily understood and accepted by doctors and patients.

From a broader industry perspective, innovative drug development is moving towards diversified pathways. Whether it's addressing real-world pain points based on mature molecules or exploring more groundbreaking new mechanisms, the ultimate goal is to return to the clinical essence: validating value through real-world data, enabling drugs to truly serve patients, and accurately responding to unmet clinical needs.

Miji Biopharma is exploring new possibilities for oral administration of paclitaxel, a mature molecule, through its SELNP delivery platform. Its core objective is not simply to extend its product line, but to validate the platform's application capabilities in real-world clinical scenarios. In the company's product portfolio, MJC-001 chose the R&D approach of "optimizing mature molecules" as its entry point, reflecting a comprehensive consideration of clinical certainty, technical feasibility, and clinical value.

Huang Huiyu also emphasized that starting with improved drugs does not limit the company's long-term innovation boundaries. The SELNP platform itself has the potential for cross-molecule and cross-scenario extension, providing a technological foundation for the company's subsequent FIC and BIC projects with higher levels of innovation.

From this perspective, MJC-001 is more like the first step for the platform to move towards the clinical system, rather than a single definition of Amagene's innovation path. As the investment and financing environment returns to rationality and clinical data is gradually realized, the true value of innovative companies that emphasize platform capabilities and clinical certainty may transcend conceptual narratives and be truly understood and ultimately validated by the market in the practice of serving patients and responding to clinical needs.

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