Pharma-MedTech Innovation Forum Tour and CBIB Index Key Park Showcase Event – Hangzhou Station Successfully Concluded!

On November 3, 2022, under the guidance of the Chinese Society for Biotechnology and the Economic, Scientific and Technological Bureau of Qiantang District, and jointly hosted by Huoshi Shulian and the Zhejiang Provincial Brain of the Biopharmaceutical Industry, with strategic support from WuXi AppTec’s China Medical Device Testing Center and Shanghai WuXi Biologics Co., Ltd.“Pharmaceutical and Medical Device Innovation Forum” Campus Tour & CBIB Index Key Industrial Park Showcase [Hangzhou Stop]Successfully held in Hangzhou Medical Port Town. The event, themed “MICE” model, inviting representatives from industry-leading CXO companies and clinical registration review experts to hold a salon on innovation trends and technologies in pharmaceuticals and medical devices. The event features a morning session dedicated to pharmaceuticals and an afternoon session focused on medical devices, along with an on-site resource matchmaking meeting involving 15+ service providers across the pharmaceutical and medical device innovation value chain.

Hong Weida, Deputy Director of the Hangzhou Medical Port Management OfficeInvited to attend the event and deliver a speech. Director Hong stated that Hangzhou Medicine Port, as a key industrial park featured in the "China Biopharmaceutical Industry Development Index CBIB 2.0," is the only industrial functional zone in Zhejiang Province that integrates a 10,000-mu, 100-billion-yuan new industry platform, a characteristic town, an industrial innovation service complex, and an industrial innovation center. It also serves as the core carrier for the provincial and municipal biopharmaceutical industries. In recent years, with the assistance of Firestone Creation, the Hangzhou Medicine Port Management Office has actively promoted “Construction and Operation of the Qiantang District Biopharmaceutical Industry Brain in Zhejiang ProvincePilot Initiatives. In terms of market-side services, by combining digital integration with offline activities, we focus on addressing the challenges of achieving close collaboration and highly integrated information sharing among upstream and downstream enterprises in the industrial chains of small and medium-sized enterprises (SMEs) in Zhejiang Province. This approach helps biopharmaceutical companies promote collaborative industrial innovation, shorten innovation cycles, reduce costs, and improve product quality, thereby resolving resource matchmaking issues for biopharmaceutical SMEs. Going forward, the Zhejiang Biopharmaceutical Industry Brain will continue to empower Qiantang Pharmaceutical Enterprise Services, supporting enterprises throughout their growth and development.

Liu Jiayu, Operations Director at Huoshi Digital ChainAs the moderator of this conference, I extend my sincere welcome to all attendees and express our appreciation for “Market-Side Services of Zhejiang Provincial Biopharmaceutical Industry Brain”delivered a presentation and shared insights. According to Ms. Liu, the market-oriented side of the Industrial Brain facilitates scenarios such as “direct service access,” “technical training,” and an “application marketplace.” By leveraging data intelligence and network collaboration, it accelerates innovation among Zhejiang Province’s biopharmaceutical enterprises, efficiently matches resources and services for companies within industrial parks, and prioritizes connecting local resources with local businesses.

Morning Pharmaceutical Salon,Wang Subiao, Deputy Director of the Drug Registration Division, Zhejiang Provincial Medical Products AdministrationAs the first guest speaker, he brought to everyone《Pharmaceutical Change Management》Keynote Address. Director Wang provided a detailed explanation of the key provisions and considerations in policies and regulations such as the Measures for the Supervision and Administration of Drug Production, the Measures for the Administration of Drug Registration, the Good Clinical Practice for Drug Trials, and the Measures for the Administration of Post-Approval Changes to Drugs, focusing on four aspects: China’s drug registration regulatory framework, the drug supervision and administration system, and the management of pre- and post-approval changes. He encouraged enterprises to innovate in drug research and development and to foster a cohort of high-quality, internationally competitive CROs.

Zhang Yifeng, Assistant Director of the Protein Sciences Department at WuXi BiologicsThe theme of this event sharing is“Expression and Purification Strategies for Bispecific Antibodies in the Early R&D Stage”He delivered an insightful presentation to the attendees, focusing on two key areas: the application of high-throughput expression and purification platforms in antibody screening during early-stage R&D, and purification strategies for bispecific antibodies, illustrating his points with relevant case studies. According to Zhang Yifeng, research-grade protein production typically faces the challenge of long lead times, generally requiring 7–8 weeks. In contrast, WuXi Biologics’ WuXian™ 777 one-stop protein production platform requires only seven days each for gene synthesis, protein expression, and protein purification, making it highly suitable for protein production in the early stages of research and development.

NovoGlobe Chief Medical Officer Li JigangWith 15 years of experience in clinical R&D and medical affairs, he has led the development strategies for over 50 innovative drugs. At this event, he《Innovative Drug R&D Strategies and Risk Control under the Internationalization of Regulatory Standards》As the keynote address, it provided a comprehensive overview of the trends and challenges in the internationalization of regulatory standards, the advantages and disadvantages of single-arm Phase II trials along with evolving regulatory policies, and risk control strategies and innovative methodologies for Phase III studies. Packed with valuable insights, the presentation received unanimous acclaim from the audience.

Li Peng, General Manager of Guoke Yisai"Surrounding""Registration Pathways and Review Considerations for Cell Therapy Products"Using CAR-T products as an example, this session outlined the regulatory submission process and strategies for cell therapy products to attendees. It also analyzed the key review considerations of the Center for Drug Evaluation (CDE) in light of the regulations and technical guidelines issued by the CDE.

Zhang Xichen, General Manager of Yi'an JishiWith 29 years of experience in the pharmaceutical and biopharmaceutical industries, he has extensive expertise in product quality, GMP manufacturing, CMC development for clinical products, CTA/MA strategies, and commercial product lifecycle management. During this event, he discussed topics including Product Quality Attribute Assessment (PQAA) & Product Quality Risk Assessment (PQRA), quality standards, process characterization and validation, and change bridging.“Product Quality Strategy for Innovative Biologics”Keynote Presentation. Dr. Zhang stated that the CMC development of large-molecule biologics faces numerous challenges due to a series of factors, including complex molecular structures, a wide variety of drug products, accelerated new drug development timelines, requirements for consistency in product performance before and after manufacturing changes, and cost control. Establishing a scientific, rational, and compliant product quality system and strategy can effectively support the rapid development of new drugs. Easymed Bioscience boasts a world-class CMC team, bioprocessing platforms, and infrastructure, which help accelerate drug development and future commercialization while reducing production costs and strengthening product control.

Afternoon Medical Device Special Session Salon,Shen Qianting, Secretary of the Zhejiang Medical Device Innovation Service AllianceAs the opening guest, provided a detailed introduction to 《"Support and Digital Service Platform for Testing Innovative Medical Devices"According to Teacher Shen, the Zhejiang Institute for Medical Device Testing has, in recent years, provided testing and technical services to medical device enterprises through initiatives such as the “100% Support for Innovations in Zhejiang-Made Medical Devices” campaign and innovation vouchers. The institute has also launched an online platform for end-to-end testing service processing—the Customer Service Platform—while optimizing offline administrative procedures. These efforts aim to progressively achieve full electronification, digitalization, informatization, and transparency of the sample submission process. Everyone is welcome to access the platform and experience its services.

Zhu Dan, Deputy General Manager of Zhoutong HealthDelivered to the on-site audience insights on the requirements for Post-Market Surveillance (PMS), the requirements for the vigilance system, the role of EUDAMED in PMS and vigilance, and the implementation dates for PMS and vigilance."EU IVDR Requirements for Post-Market Activities"keynote address. Zhu Dan stated that the substantial increase in regulatory requirements in recent years has had a significant impact on manufacturers, particularly small and medium-sized enterprises (SMEs). He recommended that IVD manufacturers initiating post-market activities in the European Union should begin preparations as early as possible, assess whether product classification and conformity assessment routes are affected, and conduct internal audits to ensure that technical documentation complies with the latest technical and linguistic requirements. Meanwhile, manufacturers need to stay abreast of changes under the IVDR, perform internal gap analyses, strengthen supply chain management, and select a stable and experienced notified body, among other measures.

Ji Chengxue, Founder of Shanghai Bisheng, specializing in clinical strategy and medical writing for medical devices for many years, with experience in managing clinical evaluation projects for nearly 200 equivalent medical devices across more than 15 therapeutic areas. At this event, Mr. Ji will present on-site"How to Choose the Right Clinical Evaluation Strategy for Medical Devices and Get on the Fast Track for Registration"In her keynote address, she shared with attendees the four key considerations for clinical evaluation strategies: regulatory considerations related to clinical evaluation strategies, qualifications of clinical evaluation personnel, timing considerations for developing clinical evaluation strategies, and preparation of documentation for strategy development. Packed with practical insights, her presentation offered highly valuable reference for manufacturers engaged in the research and development of innovative medical devices. She emphasized that clinical evaluation strategies for medical devices should prioritize “speed, precision, and stability.” By selecting the right strategy to expedite the regulatory submission process, products can reach the market earlier, thereby enabling both patients and companies to benefit sooner.

The final speaker isLv Hua, Head of UDI Application and Coding Technology at Zhejiang Institute of Standardization. She has many years of experience in traceability technology research within the healthcare industry, primarily responsible for promoting GS1-based UDI technology. During this event, Ms. Lv focused on“GS1 Standards: The Cornerstone of UDI and Traceability”This topic was elaborated in detail from three aspects: GS1 and global UDI implementation, common issues in UDI system implementation, and UDI and traceability. According to her introduction, the Unique Device Identification (UDI) is a code composed of numbers, letters, or symbols attached to medical device products or packaging, used for unique identification of medical devices, including product identifiers and production identifiers. Among the globally recognized UDI issuing agencies, GS1 is currently the only standard system that meets global UDI requirements. The GS1 standard enables full supply chain traceability from manufacturers to patients.

As a leading industrial internet platform for China’s biopharmaceutical sector, Huoshi Shulian is dedicated to providing biopharmaceutical enterprises with optimally allocated resources and services across the entire industry value chain, helping them build more advanced R&D and supply chain systems. For this event, Huoshi Shulian has organized over 15 high-quality pharmaceutical and medical device service providers to present their offerings to R&D and manufacturing companies within and around the Hangzhou Medical Port.

Chengyao Biotech (top left), Amazon Web Services (top right)

Yuanheng (bottom left), Beilanbo (bottom right)

During the morning pharmaceutical-themed salon session, four upstream suppliers—Bellembert, Chengyao Biotech, Amazon Web Services (AWS), and Yuanheng—participated in the resource promotion segment, introducing their respective flagship products and service offerings to the attending corporate guests.

In addition, the organizers of the “Pharmaceutical and Medical Device Innovation Forum” Park Tour set up special exhibition zones and a fun stamp-collecting activity for attendees, recruiting more than 10 high-quality pharmaceutical and medical device suppliers to exhibit. The on-site audience was highly enthusiastic, flocking to booths to engage in face-to-face communications with suppliers and discuss potential collaborations, creating a vibrant and bustling atmosphere.

Notably, during this event, Huoshi Shulian distributed the China Biopharmaceutical Industry Resource Handbook to all attending guests. The handbook features over 100 high-quality service providers across the entire industry chain, facilitating more efficient connections to industrial resources. It covers drug R&D and manufacturing services, medical device R&D and manufacturing services, digitalization services, instruments, equipment, reagents and consumables, general services (including talent, legal, patent, environmental protection, facility design, etc.), and industrial parks.