China's Fourth Round of National High-Value Medical Consumables Centralized Procurement Imminent; Medical Device Administration Law Added to Legislative Agenda; Domestic High-Throughput Gene Sequencer DA500 Approved

Sep 10, 2023 15:24 CST Updated 15:24

MGI

Gene Sequencing Instruments and Related Reagent & Consumables R&D Manufacturer

Ronovo

Minimally Invasive Surgical Robot Developer

VISHEE

Developer, Manufacturer, and Distributor of Rehabilitation Medical Devices

Mindray

Medical Device R&D Manufacturer

Puncture Robotic

Medical Robot Developer

Biotyx Medical

Developer of Biodegradable Vascular Materials and Stents

Market reports show that the National Organization for High-Value Medical Consumables Joint Procurement Office ("Joint Procurement Office") recently issued a document notifying member units to convene a meeting. The meeting agenda includes introducing the follow-up arrangements for the fourth round of national centralized bulk procurement of medical consumables and assigning medical institutions to report quantities.

It is reported that this meeting will be held on September 12, during which the Joint Procurement Announcement for Artificial Crystals and Sports Medicine Medical Consumables Organized by the State (No. 1) will be signed.

An intraocular lens (IOL), also known as an artificial crystalline lens, is a type of artificial lens made from polymer materials. It is surgically implanted into the eye to replace the natural lens that has been removed. Typically, it consists of a circular optical part and surrounding support loops. Intraocular lens surgery is an effective treatment for cataracts. According to incomplete statistics, intraocular lenses have undergone at least six rounds of provincial or inter-provincial alliance procurement.

Sports medicine mainly focuses on the diagnosis and treatment of injuries related to or affecting movement, including bones, joints, muscles, tendons, ligaments, cartilage, and synovial membranes. According to the previously leaked "Draft Proposal for the Fourth Round of National High-Value Medical Consumables Centralized Bulk Procurement Plan," the sports medicine-related consumables included in this procurement are anchor screws, sutures for repair, interface fixation screws, transverse fixation screws, cartilage fixation screws, soft tissue fixation screws, adjustable fixation plates, non-adjustable fixation plates, artificial ligament systems, meniscus repair and transplantation systems, arthroscopic accessory systems, pulse lavage, drill bits, grinding heads, planers, xenogeneic bone, allogeneic bone, synthetic bone, and bone morphogenetic proteins.

In the previous three rounds of national high-value consumables procurement in China, the products involved included coronary stents, artificial joints, orthopedic spinal consumables, etc., with an average price reduction of over 80% for the winning bids. The fourth round of national consumables procurement will officially start soon, and the prices of related products are expected to decrease.

What "medical device" news is worth paying attention to in the medical device industry this week? Insights into new industry policies, observations of corporate updates, and a review of market investments and financing are all covered in the tracking reports by the *Pharmaceutical Economy News*!

Insights into New Industry Policies

《Medical Device Administration Law Included in Legislative Plan for the First Time

On September 7, Xinhua News Agency authorized the release of the legislative plan of the 14th Standing Committee of the National People's Congress, including three categories of legislative projects.Among them, the first category includes "79 legal drafts that are relatively mature and proposed for deliberation during the term," the second category includes "51 legal drafts that need to be expedited and proposed for deliberation when conditions are ripe," and the third category includes "legislative projects for which legislative conditions are not yet fully available and require further research and论证."

In the 19th item of the second category, the Medical Device Administration Law is listed, marking the first time that the Medical Device Administration Law has been included in the legislative plan.

In recent years, with the continuous deepening of the reform of the medical device review and approval system and the continuous release of policy dividends encouraging innovation, the face of China's medical device industry has been completely renewed. The legislative plan of the 14th Standing Committee of the National People's Congress is the "master blueprint" for legislative work in the next five years. This time, the inclusion of the Medical Device Administration Law in the second category of legislative projects reflects the importance of relevant legislative work.

Promote the National Uniformity of Medical Consumables Codes to Enhance the Efficiency of Medical Insurance Payments

On September 5, the National Healthcare Security Administration officially announced the "Notice on Doing a Good Job in the Payment Management of Medical Consumables for Basic Medical Insurance."

The Notice mainly covers four major aspects: consolidating the foundation of medical insurance payment management, strengthening medical insurance access management, improving medical insurance payment policies, and ensuring organizational implementation, with a total of fifteen items.

The Notice pointed out that, on the premise of adhering to the functional positioning of "ensuring the basic," during the "14th Five-Year Plan" period, all provinces in China should complete the formulation of a unified provincial medical consumables medical insurance directory according to the access method and establish a sound dynamic adjustment mechanism. On this basis, the state will gradually formulate a unified national medical consumables medical insurance directory.

According to the requirements, local areas are actively promoting the application of the national medical insurance medical consumables codes. They timely update according to the medical consumables classification and code database formulated by the National Healthcare Security Administration, improving the accuracy and standardization of medical consumables code application. This ensures that medical consumables are procured, used, settled, and regulated with codes, guaranteeing the uniformity of medical consumables classification and codes across China.

Clearly Define the Scope of Medical Consumables Covered by Medical Insurance. To adapt to the principle of "separating technical labor from material consumption" in medical service price reform, strengthen the linkage between medical service price items and medical consumables payment management, and gradually include disposable medical consumables not covered by medical service item prices into the scope of medical insurance payment management according to regulations.

The National Healthcare Security Administration will study and establish a generic name management system for medical consumables covered by medical insurance, gradually formulate naming rules for generic names of different categories of medical consumables, and compile medical insurance generic names.

Fujian Introduces Policies to Promote High-Quality Development of the Biomedical Industry

On September 4, the Department of Industry and Information Technology of Fujian Province and eleven other departments issued the "Notice on Further Implementing Several Measures of the 'Implementation Plan for Accelerating the High-Quality Development of the Biomedical Industry in Fujian Province'."

The plan proposes 20 specific measures from six aspects, aiming to accelerate the enhancement of Fujian Province's competitiveness and overall strength in the biopharmaceuticals industry.

According to the requirements proposed by the measures in expanding the industrial scale, Fujian Province will further optimize the industrial development layout. The coastal areas will focus on Xiamen City to create one leading cluster, while the inland areas will focus on Sanming City to build one important production base, driving a group of parks to develop professionally, in clusters, and with distinctive features. By 2025, about five characteristic biomedicine industrial clusters will be built, and the province's pharmaceutical industry revenue aims to reach 120 billion yuan.

In order to achieve this phased goal, Fujian Province will cultivate a group of leading enterprises in niche fields. For projects listed as key technological transformation projects in the province, the provincial finance will provide subsidies for equipment investment and interest discounts on financing; actively foster competitive leading enterprises, support mergers and acquisitions, and grant a one-time reward of 3 million yuan from the provincial finance to enterprises whose annual operating income exceeds 10 billion yuan for the first time.

In terms of optimizing and innovating product services, it is specifically proposed to exempt the fees for drug re-registration and the initial registration, change registration, and renewal registration of Class II medical devices within China, thereby reducing the burden on enterprises.

Observation of New Trends in Enterprises

China-Made High-Throughput Gene Sequencer Approved by NMPA

On September 5, Suzhou Beikang Medical Instrument Limited Company's developed high-throughput gene sequencer DA500 obtained the Class III medical device registration certificate approved by the National Medical Products Administration.

As an advanced high-throughput gene sequencer produced in China, the DA500 adopts rolling circle replication amplification technology and is equipped with a patterned array slide, significantly improving sequencing accuracy. It supports two different chip specifications and can generate data throughput ranging from 10Gb to 150Gb. Clinically, it can be used for genetic disease screening at all stages of the reproductive cycle, including pre-pregnancy, prenatal, pre-implantation of embryos, and newborns.

In addition, based on the DA500 sequencing platform, Suzhou Beikang Medical Instrument Limited Company has developed the first integrated pre-implantation embryo testing kit in China, which is capable of detecting clinical conditions such as triploidy, haploidy, ROH, and parental origin issues of CNVs that are difficult to resolve with current high-throughput sequencing technologies, filling the gap in clinical detection for related diseases.

MGI Partners with Eight Enterprises to Jointly Develop G99-based Application Expansions

On September 3, at the "Gather Momentum for Strength, 'Sequence' Unlimited Power" 2nd China-produced Sequencing Alliance Summit and IVD Ecosystem Partner Empowerment Conference, MGI held the "DNBSEQ-G99 Signing Ceremony" and reached cooperation with eight enterprise partners to jointly develop application expansions based on G99.

MGI Signs Cooperation Agreements with Aoling Medical, Dian Diagnostics, FlySEQ Biotech, BGI, Jinshi Medical, DeepGene, Yunkang Group, and Usun Medical to Jointly Build an Ecosystem for the Life Science Industry Based on DNBSEQ-G99 and Promote the Development of the Life Science Industry. It is reported that based on the DNBSEQ core technology, the G99 adopts a triangular matrix signal site layout on sequencing chips for the first time, achieving higher density data output on smaller chips, with a total machine throughput of 8-48Gb.

Ronovo Surgical's Haishan-1® Robotic Surgical System Completes First Human Clinical Trial

Recently, China's first modular surgical robot, Haishan No.1®, completed its first-in-human clinical trial (FIM). This groundbreaking product, independently developed by Ronovo Surgical, a pioneer in China’s laparoscopic surgical robot innovation, is equipped with proprietary intellectual property rights and breaks the monopoly of foreign integrated surgical robots. The technical implementation of China-produced modular surgical robots marks a new milestone in China's surgical robotics industry.

The first patient in this initial human clinical trial was a 66-year-old male diagnosed with prostate cancer through a prostate biopsy. His Gleason score was 4+4=8, and he was advised to undergo radical prostatectomy. The entire surgical procedure went smoothly, taking just over an hour. Post-surgery, the patient experienced mild pain. In the following days, the pelvic drainage tube was removed, he began walking, resumed a normal diet, and recovered well, eventually being discharged smoothly.

VISHEE Announces Expected Clinical Report and Registration Submission for Picosecond Laser Therapy Device by End of Year

VISHEE recently disclosed in its investor relations activity record that the company is continuously increasing its R&D efforts for a picosecond laser treatment device with industry-leading pulse width and single-pulse energy metrics. Clinical reports are expected by the end of 2023, with registration to be submitted thereafter.

The company also acknowledged that the decline in the number of maternity patients has objectively led to a slowdown in the rapid growth of postpartum rehabilitation demand in hospitals. However, pelvic floor rehabilitation is a treatment method targeting all populations with pelvic floor disorders, including middle-aged and elderly women with needs in gynecology, urology, and proctology departments. Therefore, the overall patient population has not significantly decreased. In the field of pelvic floor rehabilitation, the company has expanded its development towards patients with pelvic floor dysfunction in both genders, showing a gradually stabilizing and improving trend. In the future, the company will continue to strengthen its promotional efforts in gynecology, urology, and proctology fields.

Mindray's Wuhan Base Project Has Been Fully Topped Out

Recently, the Mindray Wuhan Base project has been fully topped out and will be put into use gradually by the end of this year and early next year.Mindray's Wuhan Base Has a Total Investment of 4.5 Billion Yuan, Including Two Sub-Projects: The Wuhan Research Institute and The Manufacturing Base, with a Total Construction Area of Approximately 530,000 Square Meters.

Among them, the Mindray Wuhan Research Institute project is located in the Optics Valley Biomedical Industry Park, Medical Device Park. The project construction content includes biomedical engineering research and development, such as but not limited to biological raw materials and reagent R&D, surgical equipment R&D, health technology R&D, as well as a global service support center, an engineering technology transformation center, and corresponding supporting facilities.

Mindray's Wuhan Production Base Project is located in the Jiulong Industrial Base, with a total construction area of 240,000 square meters. The project involves the production and manufacturing operations of medical devices and biological raw materials, including but not limited to orthopedic implants and surgical treatment equipment manufacturing, in vitro diagnostic reagent production, biological raw material preparation, minimally invasive surgical equipment manufacturing, healthcare device manufacturing, as well as corresponding supporting facilities.

Market Investment and Financing Review

Beijing Leo Summit Biotechnology Co., Ltd. Completes Tens of Millions of Yuan in Pre-A Round Financing, Led by Jianyi Capital

On September 8, it was reported that Beijing Leo Summit Biotechnology Co., Ltd. completed a Pre-A round of financing worth tens of millions of RMB.This round of financing was led by Jianyi Capital, with existing shareholder Huagai Capital continuing to support.This is the company's second round of financing following the angel round last year, which was jointly led by Huagai Capital and Kangqiao Capital.The funds raised will be mainly used for the industrialization and implementation of intelligent, nanoliter pipetting workstations, as well as the delivery of system integration solutions.

Beijing Leo Summit Biotechnology Co., Ltd. positions itself as a provider of life science laboratory automation solutions. Driven by the demand for automated and intelligent technologies in clinical medicine and drug development industries, and relying on artificial intelligence and motion control technologies, it offers reliable, flexible, efficient, and intelligent laboratory automation products to the biopharmaceutical industry.

Leyi Biotech Completes Angel+ Round Financing to Continuously Advance Clinical Research of Core Products

It was reported on September 8 that Hangzhou Leyi Biotechnology Co., Ltd. completed its Angel+ round of financing in August.From 2022 to 2023, Leyi Bio has completed three rounds of financing, including seed round, angel round, and angel+ round, with a total financing amount reaching tens of millions of RMB. The investors include Thunder Capital, Yuhang Financial Control, etc.This round of funding will be used to continuously increase investment in independent innovation and R&D, steadily advance the clinical research of core products, and comprehensively enhance market competitiveness and brand influence.

Leyi Biotech focuses on the research and innovation of cutting-edge biotechnologies in the field of breath diagnostics, aiming to achieve rapid diagnosis and early screening of various digestive system diseases through human breath testing. It is a comprehensive enterprise integrating R&D, production, sales, and service.

Puncture Robotic Secures Additional Tens of Millions in A++ Round Financing!Lead the Way in China-Produced Hair Transplant Robots

Following the completion of a nearly RMB100 million Series A+ round in July, Puncture Robotic (Shanghai) Intelligent Medical Technology Co., Ltd. recently announced the completion of a multi-million yuan Series A++ round.This round of financing was exclusively invested by Huading Investment, with Probe Capital serving as the exclusive financial advisor.The funds raised will be used for clinical certification, capacity enhancement, and global promotion, comprehensively accelerating the arrival of the global intelligent FUE era.

Puncture Robotic is a developer of image-guided surgical robots that integrates advanced technologies. Relying on the robotics technology foundation of Harbin Institute of Technology, the company has established real-time image-guided technology and an "AI+Robot+Image Soft Tissue Intervention Technology Application Platform." It has developed several robotic products for clinical applications such as puncture procedures, tumor interventional therapy, biopsies, anesthesia, and medical aesthetics. The company is committed to creating better equipment and conditions for medical services, enabling advanced technology to serve humanity worldwide.

PILOT Gene Technologies Completes Nearly 100 Million Yuan in Series B Financing, Led by Simiao Capital

Recently, PILOT Gene Technologies, a leading enterprise in China's digital PCR industry, announced the completion of a new round of financing worth nearly 100 million yuan. This round of financing was led by Simiao Capital, with existing shareholders also increasing their investment. Xuejian Capital served as the exclusive financial advisor for this round and will continue to act as the financial advisor. The funds will mainly be used for the research and development of fully automatic instruments and POCT equipment, subsequent production and sales of Class III reagent certificates, and the expansion of overseas business.

PILOT Gene Technologies is a knowledge-intensive high-tech innovation enterprise. The company is committed to the research and development of molecular diagnostic products based on global cutting-edge technologies. These mainly include Digital PCR (dPCR) technology and Single-cell Sequencing (SCS) technology, with the aim of applying the latest diagnostic products in clinical reagents and providing customers with comprehensive solutions.

Biotyx Medical Completes Over 200 Million Yuan in Series B Strategic Financing, Jointly Invested by GQH Capital, GF Qianhe, and Others

Recently, it was reported that Biotyx Medical (Shenzhen) Co., Ltd. has successfully completed a B-round strategic financing of over 200 million yuan.This round of financing has introduced several strategic investors, such as共青城华屹and广发乾和. A-round investors IDG and上海抱泉continued to follow up on their investments. The B-round capital increase agreement and shareholder agreement have now been signed.The investors of this round of financing will invest more than RMB 200 million in Biotyx Medical (Shenzhen) Co., Ltd. according to the agreement of the capital increase contract.

According to publicly available data, Biotyx Medical is the world's only enterprise engaged in the research and development of iron-based bioabsorbable stents. With advanced scientific research conditions and a high-level R&D team, the company is committed to developing excellent innovative interventional device products to serve a wide range of patients and address unmet clinical needs globally. It has successfully developed multiple fully degradable iron-based bioabsorbable stent products, which are applied in several mainstream fields such as coronary heart disease, pediatric pulmonary artery stenosis, and infrapopliteal artery stenosis.