Breakthrough in 4th‑Generation MEMS Microneedle Technology: Xinsiyuan Biotech Leads The Wave Of Domestic Substitution
May 12, 2026
Microneedle technology is undergoing a leap‑forward upgrade from conventional manufacturing to MEMS (Micro‑Electro‑Mechanical Systems) processes, with Xinsiyuan Biotech taking a leading domestic position in this technological revolution. In September 2025, the company's self‑developed Medical Microneedle Transdermal Patch obtained Class II medical device certification from the NMPA, marking a landmark domestic breakthrough in 4th‑generation MEMS‑based microneedle technology.
Core Performance Indicators of the Technological Breakthrough
Xinsiyuan Biotech's 4th‑generation MEMS microneedle technology achieves remarkable advances: puncture accuracy within ±0.02 mm, a 300 % increase in drug‑loading capacity, and biocompatibility exceeding 98 %. Compared with traditional moulding and CNC machining, the technology cuts fixed investment for disposable production lines by more than 70 % and significantly lowers operating costs, with ex‑factory product costs reduced to less than half of conventional levels. Notably, the company has developed an ultra‑large 200 cm² pure sodium hyaluronate microneedle patch, while competing Japanese and Korean brands of the same period only achieve a forming area of 7–10 cm². The product attains internationally leading levels in three key metrics: needle‑tip sharpness, mechanical strength of microneedles, and single‑shot forming area.
Industrial Layout
Xinsiyuan Biotech has established a strategic partnership with Feifan Pharmaceutical, aiming to help downstream partners build a production capacity of 100 million medical microneedle patches by the end of 2026. The collaboration creates a dual‑driven "technology + market" ecosystem. Leveraging its market network covering key East‑China regions such as Jiangsu, Hunan and Shandong, Feifan Pharmaceutical provides technical empowerment and targeted promotion for Xinsiyuan Biotech.
Market Outlook
According to Grand View Research, the global transdermal drug‑delivery market is projected to exceed USD 80 billion by 2028. Beyond breaking foreign technological monopolies, Xinsiyuan Biotech integrates traditional meridian theory of Chinese medicine with modern biotechnology, delivering efficient and safe solutions for indications such as chronic pain and inflammation. The company plans to pilot its products in East‑China grassroots medical institutions and collaborate with industry associations to formulate technical standards for MEMS microneedles.
Comparative Technical Advantages
Xinsiyuan Biotech's proprietary RT‑SMP® Room‑Temperature Printing Method addresses the full‑chain challenges in flexible polymer microneedle forming. The technology features three core strengths:
1. Room‑temperature activity preservation: prevents thermal degradation of active ingredients;
2. flexible and tunable parameters: precise control over microneedle height, array density, and patch macro‑geometry;
3. cross‑domain compatibility: enables production of soluble monolithic microneedles, soluble layered microneedles, and swellable microneedles for diverse formulations.
