On September 10, 2025, the “Medical Microneedle Transdermal Patch” (trade name: Acupoint Patch with Intradermal Needles), independently developed by Xinshiyuan Bio, was classified by the Medical Device Standards Management Center of the National Medical Products Administration as a Class II medical device (classification code: 20-03). This milestone marks a breakthrough in China’s fourth-generation microneedle technology based on MEMS manufacturing, opening new avenues for the cross‑disciplinary integration of traditional Chinese medicine’s meridian theory and modern biotechnology.

During the same period, Changzhou Feifan Pharmaceutical Information Consulting Service Co., Ltd. (hereinafter referred to as “Feifan Pharmaceutical”) and Novelty Pharmaceutical Co.,Ltd (hereinafter referred to as “Xinshiyuan Bio”) jointly announced that their comprehensive strategic partnership agreement has undergone a major upgrade.

A Powerful Partnership: Building a Dual-Drive Ecosystem of “Technology + Market”

Under the upgraded strategic cooperation agreement, Feifan Pharmaceutical will leverage its market network spanning key eastern China regions such as Jiangsu, Hunan, and Shandong, along with its vertical‑industry community resources—including industry associations and universities—to provide Xinshiyuan Bio with dual‑engine support—technology and market—specifically including:

♦ Enhanced Authority: Professor Zeng Jinshui, CTO of Xinshiyuan Bio, will participate extensively in academic promotion as a “Gold Medal Lecturer” and “Specially Appointed Consultant” for Feifan Education. The fourth-generation microneedle technology based on MEMS processes, developed by his team, achieves puncture accuracy within ±0.02 mm, increases drug-loading capacity by 300%, and attains a biocompatibility rate exceeding 98%. This groundbreaking technology has been recognized with national-level awards and is protected by multiple invention patents.

♦ Precise Needs Identification: Jointly develop microneedle transdermal technology solutions tailored for Grade‑III hospitals, traditional Chinese medicine institutions, and health‑and‑wellness facilities; concurrently launch multi‑center clinical trials; and plan to conduct research on dermatological conditions and chronic diseases of the superficial subcutaneous tissues at Grade‑III hospitals in the Yangtze River Delta region by 2026.

♦ Accelerating production capacity deployment: Leveraging NewWorld Bio’s 100% in-house‑developed MEMS microneedle manufacturing equipment, the two parties plan to help downstream partners establish a production capacity of 100 million medical microneedle patches by the end of 2026.

Professor Zeng Jinshui: MEMS Technology Redefines the Frontiers of Healthcare

Professor Zeng Jinshui, founder and CTO of Xinshiyuan Bio, stated: “From the laboratory to the clinic, every leap forward in microneedle technology has been driven by an unwavering pursuit of precision.” He emphasized: “MEMS manufacturing has enabled microneedles to overcome traditional production bottlenecks, and our fourth-generation technology achieves nanoscale machining accuracy through proprietary equipment. Looking ahead, in the field of transdermal drug delivery using dissolvable microneedles—particularly in novel dosage forms and controlled-release technologies—we aim to elevate clinical outcomes to an internationally leading level while ensuring safety.” Related reading: Kris Tseng of Xinshiyuan Biotechnology: Dissolvable microneedles have now advanced to their fourth generation!

Industry Breakthrough: Domestic Substitution Accelerates, a Hundred-Billion-Dollar Market Takes Off

According to Grand View Research, the global transdermal drug delivery market is projected to exceed US$80 billion by 2028. As the world’s largest traditional Chinese medicine market, China is seeing MEMS-based microneedle technology drive the digital and precision transformation of conventional acupuncture devices:

♦ Breakthrough in Technological Barriers: Xingshiyuan Bio’s independently developed MEMS microneedle R&D equipment and manufacturing process have achieved 100% domestic sourcing of core components, thereby breaking the foreign technology monopoly.

♦ Clinically significant: The product integrates traditional Chinese medicine’s “acupoint stimulation” theory with MEMS-based “intelligent controlled-release” technology, offering an efficient and safe solution for indications such as chronic pain and inflammation.

♦ Vast market prospects: The two parties plan to use the East China region as a pilot site to promote the widespread adoption of their products in primary-care medical institutions, while collaborating with industry associations to develop industry standards for MEMS microneedle technology.

Feifan Pharmaceuticals: Empowering the Translation of Medical Innovation into Real-World Applications

Xing Feng, founder and chairwoman of Feifan Pharmaceutical, stated: “This collaboration not only represents complementary technological strengths but also serves as a testament to China’s growing capacity for independent innovation in high-end medical devices.” She added: “Centering on ‘technology empowerment plus precision communication,’ we will help Xingshiyuan Bio seamlessly integrate the entire R&D‑registration‑market value chain, accelerating the clinical adoption and global expansion of domestically developed innovative medical devices.”

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