"White Coat Edge Biotechnology" Secures Tens of Millions of Yuan in a New Round of Strategic Financing to Accelerate R & D of ECM Materials and Market Expansion | Exclusive Report by 36Kr

Text | Hu Xiangyun

Editor | Hai Ruojing

36Kr learned that "Baiyiyuan Biotech", an enterprise in the field of regenerative medicine, recently received tens of millions of RMB in financing. This round of financing was exclusively invested by listed company Kantar Pharmaceutical. The raised funds will be mainly used for new product R & D, market expansion, and production line upgrading. Mian Capital served as the long - term strategic chief financial advisor, assisting Baiyiyuan Biotech to reach a comprehensive strategic cooperation on equity and products with Kantar Pharmaceutical.

Baiyiyuan Biotech was established in 2011 and focuses on the R & D and production of new biomedical materials products such as tissue repair, wound healing, and regenerative medical aesthetics represented by extracellular matrix (ECM). The company has now built a R & D center and a GMP industrialization base in Shanghai and obtained the high - tech enterprise certification in 2019.

Currently, the company mainly uses porcine small intestinal submucosa extracellular matrix (SIS - ECM), an animal - derived tissue regeneration material, as an entry point, continuously expands multi - system ECM materials such as AAM, and builds its own technology platform and product matrix. It is reported that the company's initially promoted SIS - ECM is mainly derived from the porcine small intestinal submucosa, which has excellent biocompatibility, is rich in collagen and growth factors, can induce cells to diffuse, adhere, grow, and proliferate inward, and plays an important role in the self - repair and regenerative reconstruction of tissue defects.

Image source: Baiyiyuan Biotech official website

Dr. Han Baiyi, the founder and chairman of the company, introduced that the reason for choosing animal - derived materials instead of the more popular humanized ECM or artificially synthesized biomimetic ECM in the current market is mainly due to the following reasons: First, from a technological perspective, the decellularization process, purification and sterilization methods of animal - derived materials are already mature. The products made from them are less likely to cause immune rejection reactions and can better preserve the integrity of the extracellular matrix. From an application perspective, in the traditional serious medical field, animal - derived ECM has already been widely used, and both regulatory and market acceptance are relatively higher. In addition, in terms of the supply chain, animal - derived materials have a relatively stable and safe raw material source.

Based on these considerations, Baiyiyuan Biotech has now built two technology platforms with complete independent intellectual property rights: SIS - ECM (porcine small intestinal submucosa extracellular matrix) and AAM - ECM (acellular adipose matrix). Based on these platforms, the company has developed two core products: an absorbable biological membrane (Baijiangu®) and a dura (spinal) membrane biological patch (Baijianmo®).

The former is mainly used in guided bone regeneration (GBR) in oral dental implant treatment. Its relatively long - lasting barrier effect and induced regeneration function can provide an ideal micro - environment for bone regeneration, thereby reducing the occurrence of postoperative complications. The latter is targeted at the neurosurgery field, suitable for dural repair and reconstruction, and can reduce the risk of postoperative infection. Clinical data provided by Baiyiyuan Biotech shows that compared with similar imported products, within the same period, the bone mass loss rate of Baijiangu® absorbable biological membrane after GBR surgery is about 3 - 5%, while that of imported products is about 10%.

It is reported that both products have entered the commercialization stage and have been listed in 24 provinces across the country. In the first full - year of sales in 2024, they achieved revenues exceeding tens of millions of RMB.

It is worth mentioning that in addition to applications in the traditional medical field, Baiyiyuan Biotech is also developing ECM materials for the fields of medical aesthetics filling and hydrating products. The filling product of SIS - ECM is about to complete clinical R & D and is expected to submit a product registration application this year.

The application of ECM materials in the field of medical aesthetics anti - aging has been a research hotspot in the medical field in recent years. In the past, the "evolution" of medical aesthetics materials has basically gone through several stages: filling (physical support filling) - nutrition (supplementing nutrition through the mesoderm) - stimulation (such as polymers like PLLA (Sculptra) and PCL + CMC (Sculptra) stimulating the regeneration of collagen mother cells). The industry generally believes that in the future, its development direction will definitely be "regeneration", that is, no longer simply supplementing, but "realizing the repair and regeneration of defective tissues" through biomedical engineering technology.

The core value of ECM materials lies in that, both structurally and functionally, they are closer to the micro - environment of human cells, which is equivalent to relying on the body's natural repair ability to enable tissue/organ regeneration. "The main way for collagen stimulants such as PLLA to work is through an inflammatory reaction, which is prone to problems such as nodules. This is also the reason why people often complain about problems such as granulation and puffiness. When ECM materials enter the human body, they actually stimulate normal cell activity and produce 'normal' and functional collagen," explained Shen Chenye, COO of Baiyiyuan Biotech.

"In the past, our ECM materials have been applied in the serious medical field. When expanding to the medical aesthetics field, our core work is also to utilize our advantages in the material field to 'implant' this good cell growth environment into the human body, not limited by indications, but only by the final effect of the product," said Dr. Han Baiyi.

From a market perspective, due to regulatory differences, although there are precedents for the application of ECM materials in the medical aesthetics field overseas, there may still be a long way to go before their large - scale application in the Chinese mainland.

In this regard, Baiyiyuan Biotech believes that ECM materials "may be a new application in the medical aesthetics field", but they have been widely used in traditional serious medical treatment. "Market awareness is gradually spreading. The core issue in the future mainly lies in the review and approval attitude and speed of regulatory authorities. In this regard, Baiyiyuan Biotech has previously had two products approved and has certain experience in 'obtaining certificates'. We believe that ECM materials will soon enter the medical aesthetics market," said Shen Chenye.