Pengguan Bio: Six Years of R&D and Millions of Trials Yield China's First Absorbable Bone Wax – Featured in Artery Select New Product Showcase Episode 67

Orthopedic surgeries are often associated with a risk of bleeding, as the loose structural organization of bone wound surfaces and the poor vasoconstrictive capacity of tissues make them distinct from other surgical procedures.Intraoperative hemostasis in orthopedic surgery is more challenging, with fewer options for hemostatic materials.

Bone wax is a time-hemostatic material with a century-long history. Due to its excellent plasticity, ease of use, and rapid hemostasis, it is a commonly used material for controlling bleeding from bone surfaces.However, traditional bone wax is non-degradable, which not only impedes bone tissue repair and regeneration but also predisposes patients to foreign body granuloma formation and compromises local anti-infective capacity.

To address the aforementioned pain points,Shanghai Pengguan Biomedical Technology Co., Ltd. (hereinafter referred to as “Pengguan Biomedical”) has undergone a series of scientific and rigorous validations over the past six years, including laboratory research, biocompatibility studies, animal trials, and clinical trials., and finally succeeded in securing it this JanuaryChina's First Class III Registration Certificate for Absorbable Bone Wax, marking a breakthrough in China’s field of absorbable hemostasis for bone wound surfaces with the introduction of absorbable bone wax. As the first domestically developed “absorbable bone wax,” this next-generation clinically essential product for hemostasis on bone wound surfaces is poised to open up an entirely new blue-ocean market.。

On Friday, June 14, at 19:30, the 67th session of VCBeat Select New Product Review will feature Zhu Hongbin, General Manager of Pengguan Biomedical; Chen Xiaodong, Director of the Department of Orthopedics at Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (who leads the key participating site for Pengguan Biomedical’s Phase III clinical trial of absorbable bone wax); and Duan Dexiang, Sales Director of Pengguan Biomedical.“China’s First-of-Its-Kind Flagship Product—Guquanyu® Absorbable Bone Wax”Product Promotion.

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Zhu Hongbin

General Manager, Shanghai Pengguan Biomedical Technology Co., Ltd.

2001–2003: Head of the Institute of Pharmaceutical Research, Shanghai Desano Biopharmaceutical Co., Ltd.; awarded the Third Prize of the Shanghai Municipal Science and Technology Progress Award in 2003.

From 2003 to 2006, served as Manager of the Research and Development Department at Jiangsu Huayuan Pharmaceutical Co., Ltd. In 2004, was honored as one of the “Fourth Outstanding Scientific and Technological Workers of Taizhou City.”

2006–2009, served as Executive Deputy General Manager of Nanjing Huawei Pharmaceutical Technology Development Co., Ltd.

2009–2014, served as Director of New Drug R&D at Shanghai Qingsong Pharmaceutical Co., Ltd.

2014–2016, Executive Deputy Director of the Research Institute at Borui Biomedical (Suzhou) Co., Ltd.

Since March 2016, Co-founder, General Manager, and R&D Director of Shanghai Pengguan Biomedical Technology Co., Ltd., overseeing and guiding the research, development, and regulatory registration of high-end medical devices in the fields of critical care interventional therapy and orthopedic implants. As a principal inventor in these two areas, has obtained 5 granted invention patents and more than 20 utility model patents; successfully led the development of four Class II medical device products.

The company’s independently developed product, the first domestically produced absorbable bone wax in China, has obtained a Class III medical device registration certificate issued by the National Medical Products Administration. This product fills the gap in absorbable materials for hemostasis in the field of orthopedics in China.

Chen Xiaodong

Chief Physician, Department of Orthopedics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Chief Physician, Professor, Doctoral Supervisor, Director of Orthopedics

Principal Investigator at Key Sites in the Phase III Clinical Trial of Pengguan Bioabsorbable Bone Wax

Member of the International Society for Hip Surgery
Chairman of the Hip Preservation Group, Chinese Medical Doctor Association
Chairman of the Joint Surgery Group, Orthopedics Branch, China International Exchange and Promotive Association for Medical and Health Care
National Joint Study Group Committee Member
AO/ASIF Instructor (China Region)
Editorial Board Member of the Chinese Journal of Hand Surgery
Editorial Board Member of "Anatomy and Clinics"
Corresponding Editorial Board Member of Chinese Journal of Surgery
Corresponding Editorial Board Member of Chinese Journal of Orthopaedics
"Chinese Journal of Orthopaedic Trauma" Corresponding Editorial Board Member
"Chinese Journal of Joint Surgery" Corresponding Editor

He studied under Academician Gu Yudong and specializes in the diagnosis and treatment of peripheral nerve disorders, achieving favorable outcomes by applying endoscopic techniques to treat peripheral nerve entrapment. In 2002, he went to the University of Toronto in Canada to undertake specialized training in artificial joint replacement under Professor Waddell. In 2005, he studied at the University of Bern in Switzerland under Professor Ganz, a world-renowned expert in hip pathology, to learn the diagnosis and treatment of hip diseases. He performs periacetabular osteotomy (Ganz osteotomy) for the treatment of acetabular dysplasia in adolescents and adults. His hospital has become one of the few institutions in China capable of performing this procedure.

To date, over 5,000 hip-preserving surgeries of various types have been performed with satisfactory outcomes, attracting patients from across China. He/She has presided over or participated in seven research projects funded by the National Natural Science Foundation of China, the Shanghai Municipal Science and Technology Commission, and the Shanghai Municipal Education Commission, and has published more than 50 academic papers in domestic and international journals.

Duan Dexiang

Sales Director, Shanghai Pengguan Biomedical Technology Co., Ltd.

Responsible for the national sales of Pengguan's full product line.

Shanghai Pengguan Biomedical Technology Co., Ltd. was established in 2015 as a high-tech enterprise integrating research and development, production, and sales. Located in the Zhangjiang Innovative Drug Industrial Base in Pudong New Area, Shanghai, the company covers an area of nearly 3,000 square meters and features research-grade laboratories and Class 10,000 clean workshops. It has obtained ISO 13485 quality management system certification from Beijing Guoyixie Huaguang. The company actively engages in deep industry-academia-research-medical collaborations with domestic and international research institutes and medical institutions, developing a series of products with independent intellectual property rights, particularly in the fields of critical care gastroenterology and orthopedic implant materials.

After six years of dedicated development, Pengguan’s absorbable bone wax successfully obtained registration certification as a Class III implantable medical device in January 2024. As the first absorbable bone wax in China, it fills the long-standing gap in the domestic market for absorbable agents used in hemostasis of bone wound surfaces. Clinical validation has demonstrated that Pengguan’s absorbable bone wax exhibits excellent hemostatic efficacy and is completely absorbed within four weeks in vivo without residue, thereby not impairing bone healing. It effectively addresses the complications associated with traditional non-absorbable bone wax, such as impaired bone healing, foreign body granuloma formation, and infection.

Leading the industry through technological innovation and advancing healthcare with exceptional quality. Shanghai Pengguan Biomedical Technology Co., Ltd. remains committed to making our products your trusted assistant in surgery, providing robust safeguards for patient health.

“Artery Select New Product Launch” is a live-streaming series under “Artery Select” designed to support medical enterprises in launching innovative products. The program’s mission is to empower the milestone launch of every innovative medical product.

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