Rege-Innovation Secures Tens of Millions in Pre-A Round, Building a Full-Chain Silk Fibroin Innovation Ecosystem

Shanghai Rege-Innovation Medical Technology Co., Ltd. (hereinafter referred to as "Rege-Innovation") completed its Pre-A financing round in March of this year, led by Furong Capital, with follow-on investment from Sanxin Medical. The funds from this round will be fully directed toward three core areas: research and development of innovative medical devices based on silk fibroin, iteration of core material processes, and regulatory registration submissions across the full product pipeline.

Leveraging its three proprietary technology platforms for silk fibroin—rigid materials, hydrogels, and microspheres—Rege-Innovation continues to address critical clinical pain points, developing integrated medical material solutions tailored to clinical needs. As a regenerative biomaterial positioned at the national strategic forefront, silk fibroin is becoming an important engine driving the domestic substitution of advanced biomedical materials and industrial transformation.

Established in 2023, Rege-Innovation is a platform-type medical technology company focused on the research and development of silk fibroin materials. The company's core team is composed of senior scientists and industrialization experts in the field of silk fibroin biomaterials, with core members holding backgrounds from renowned domestic and international universities and research institutions, as well as extensive industrial experience.

Dr. Xing Rong, the founder, holds a Ph.D. in Orthopedics from Zhongshan Hospital affiliated with Fudan University, serves as a researcher at Fudan Zhangjiang Institute, and has been recognized as a Shanghai Eastern Talent. He also holds leadership positions in multiple national-level professional associations. He has previously worked at leading medical device companies such as Johnson & Johnson and at several top-tier hospitals, possessing a combined background spanning research, clinical practice, and industry.

The company is deeply integrated into Fudan University's innovation and translational ecosystem, having established strong collaborations with top research and medical institutions including Zhongshan Hospital affiliated with Fudan University, Donghua University, and Shanghai University of Medicine and Health Sciences, successfully building an integrated "industry-academia-research-medicine" innovation ecosystem.

Within the Shanghai (Nanxiang) Precision Medicine Industrial Park, jointly established by Fudan University and the Jiading District Government, Rege-Innovation has built a 3,000-square-meter research, development, and production center with Good Manufacturing Practice compliance. The facility has an annual raw material production capacity reaching the ton-level, and orthopedic and medical aesthetic products reaching tens of thousands of units, achieving industry-leading overall efficiency. To achieve source control of medical-grade raw materials, the company has also established an 800-mu standardized silkworm breeding base in Xuzhou Taoyuan through a collaborative partnership.

Outside the Rege-Innovation Factory

As a leading domestic provider of full-scenario solutions for innovative applications of silk fibroin, Rege-Innovation has built a diversified clinical product matrix addressing implantation, tissue filling and repair, and wound repair, based on three comprehensive technology platforms:

Rigid Materials Technology Platform: Focused on orthopedic and implantable rigid medical materials, this platform has overcome key challenges in high-strength, degradation-controllable, and biocompatible rigid substrate processing, addressing pain points such as poor histocompatibility and inadequate mechanical property matching associated with traditional rigid materials.

Hydrogel Technology Platform: This platform custom-develops multiple series of injectable, pro-regenerative, and highly biocompatible hydrogel systems tailored for scenarios including wound repair, regenerative medical aesthetics, and intracavitary tissue isolation.

Microsphere Technology Platform: This platform has established an industry-leading continuous and scalable microsphere preparation and control system, efficiently compatible with biomedical materials such as silk fibroin, sodium hyaluronate, and collagen. It has successfully achieved precise control of microsphere particle size under high-volume, high-capacity production conditions.

The company's first core product, the "Silk Fibroin Bone Screw and Plate System," is built upon more than a decade of technological accumulation at Zhongshan Hospital affiliated with Fudan University. Through its globally proprietary "enzymatic plus physical dual-crosslinking" patented technology, the company has successfully achieved industry-leading preparation of silk fibroin rigid materials.

Its mechanical strength exceeds that of current mainstream polylactic acid-based absorbable bone implants by more than 30%, with controllable degradation rates and no immune rejection response. This system fundamentally addresses core clinical pain points associated with traditional metallic materials, which require secondary surgery for removal, as well as the insufficient strength and propensity for aseptic inflammation seen in existing absorbable polylactic acid materials.

This orthopedic product is about to enter the clinical trial phase, while two silk fibroin hydrogel dressing products developed for wound repair are expected to obtain regulatory approval for registration in the second half of this year, potentially becoming the company's first commercially available medical device products.

The domestic substitution process for advanced medical materials in China is accelerating comprehensively, and the silk fibroin industry is entering a critical window of opportunity.

Domestically, under the top-level guidance of the Fourteenth Five-Year Plan for the biomedical industry, the Ministry of Industry and Information Technology and the National Medical Products Administration have jointly launched a special initiative for tackling key challenges in biomedical material innovation through the "task list and leadership" program.

At the international level, the industry landscape has recently reached a pivotal turning point. The international standard for "Surgical Implants – Silk Fibroin," led by China in its development, has been formally established as a project. This milestone has fundamentally broken the long-standing monopoly of European and American countries over international standards for biomaterials. For the first time, China has gained a voice in setting global standards within this subfield, which has also removed standardization barriers for companies such as Rege-Innovation, which possess full-chain independent research and development capabilities, enabling them to pursue simultaneous domestic and international regulatory submissions and facilitate product globalization.

Rege-Innovation is also taking a leading role in formulating group standards for multiple authoritative industry societies, including the Chinese Society for Biomaterials, guiding the standardized development of silk fibroin materials and their corresponding products.