Johnson & Johnson Completes Acquisition of V-Wave; Guangdong Announces Comprehensive Support for Innovative Pharmaceuticals and Medical Devices; Xinrui Medical and Tianjin Zhipu Secure New Funding Rounds

Oct 13, 2024 16:13 CST Updated 16:13

Johnson & Johnson

Medical Device R&D and Manufacturer

V-Wave

Developer of Percutaneous Implantable Devices

10Month9Recently, Johnson & Johnson, a global giant in the medical and health field, announced the completion of its acquisition of V-Wave Ltd., a manufacturer of atrial shunt devices.V-WaveThe acquisition marks another significant step in Johnson & Johnson's strategic layout in the cardiovascular field.V-WaveWill continue to operate and develop as part of Johnson & Johnson Medical.

In this acquisition, Johnson & Johnson acquired V-Wave for a $600 million upfront payment and may pay up to an additional $1.1 billion based on the achievement of regulatory and commercial milestones, totaling approximately 12.1 billion RMB.

V-Wave, established in 2009, is a privately held company dedicated to developing innovative treatment solutions for heart failure patients. Its key product, the Ventura® Interatrial Shunt (IAS), is a novel implantable device that reduces elevated left atrial pressure in patients with congestive heart failure by creating a shunt between the left and right atria, thereby decreasing cardiovascular complications and hospitalizations due to heart failure.

Cardiovascular, as the second largest细分 market in the medical device field, has seen持续 acquisitions by Johnson & Johnson in recent years. These acquisitions have not only accelerated Johnson & Johnson's transformation into high-growth, high-opportunity markets but also complemented its comprehensive medical technology portfolio in areas such as coronary artery disease, peripheral artery disease, cardiac recovery, and atrial fibrillation.

With the continuous advancement of technology and the expanding market, Johnson & Johnson's future performance in the cardiovascular field is highly anticipated.

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

Insights into New Industry Policies

Guangdong Issues Action Plan to Promote High-Quality Development of Guangdong's Biopharmaceutical Industry

On October 9, the General Office of the People's Government of Guangdong Province issued the "Action Plan for Further Promoting the High-Quality Development of Guangdong's Biomedical Industry."

The Action Plan proposes: to increase full-chain support for innovative drugs and medical devices. Municipalities with conditions should provide policy and financial support for all links in the full chain of innovative drug and medical device development, including preclinical research, clinical trials, certification approval, industrialization, promotion, and application. Provincial special funds such as the provincial science and technology innovation strategy, industrial innovation capacity building, and industrial foundation rebuilding should be coordinated to plan and layout a new round of key R&D program special projects in the province, including "high-end medical devices," "biomedicine and health," "modernization and key technology equipment of Lingnan traditional Chinese medicine," and "precision instruments and equipment." Support will be given to key core technology breakthroughs and landmark product industrialization efforts in areas such as innovative drugs, standardization and normalization of traditional Chinese medicine, high-end medical devices, high-end scientific instruments and reagents, and intelligent production equipment.

Jiangsu Activates Resumption Application Handling Module for Medical Device Companies Under停产 Rectification

On October 9, the Jiangsu Provincial Medical Products Administration announced the activation of the "Resumption Application Handling Module for Medical Device Companies Under停产整改" to be effective from October 15, 2024, aiming to enhance regulatory efficiency.

This new module applies to Jiangsu Province medical device registrants/record holders and manufacturing enterprises that have been suspended from production or ordered to cease operations due to regulatory inspections, and addresses the process of applying for resumption of production after completing rectifications.

The new module will undergo a trial operation from October 15, 2024, to January 16, 2025. During this period, companies can choose to apply either online or offline. Starting from January 16, 2025, all resumption applications must be processed through the system, and paper applications will no longer be accepted.

Observation of New Trends in Enterprises

Burning Rock Medical and Dizhe Pharmaceuticals' Co-Developed Companion Diagnostic Kit Receives NMPA Approval

On October 11, Burning Rock Biotech and Dizal Pharmaceutical jointly announced that the companion diagnostic reagent for Sunvozertinib Tablets (brand name: Sunvozertinib), which targets EGFR exon 20 insertion mutations (exon20ins), received approval from China's National Medical Products Administration (NMPA).

The approval of this companion diagnostic is based on the synchronous development and completion of Burning Rock's self-developed LungSeek® CDx (Human 9-Gene Mutation Combined Detection Kit) and Dizal Pharmaceutical's innovative EGFR exon20ins targeted drug - Sunvozertinib, providing an innovative precision diagnosis and treatment solution for patients with EGFR exon20ins non-small cell lung cancer. This is the first companion diagnostic kit in the field of lung cancer based on the NGS technology platform that has been approved by the NMPA after the issuance of China’s companion diagnostic reagent guidelines.

Aimeike's Second Long-Acting PVA Microsphere Hyaluronic Acid in China Officially Approved

On October 9, Aimeike announced that its "Cross-linked Sodium Hyaluronate Gel Containing Polyvinyl Alcohol Microspheres for Medical Use" has been officially approved by the National Medical Products Administration (NMPA), with the registration number: China Medical Device Registration Certificate No. 20243131967. The product is indicated for subperiosteal injection in adults to improve mild to moderate chin retrusion.

Bone materials mainly include PMMA (polymethyl methacrylate), PVA (polyvinyl alcohol), and PCL (polycaprolactone), etc. Representative products in China are Artecoll® by Hanford of the Netherlands, Bonita® by Aimeike, Ellansé® by Huadong Medicine, and Suyanzhen® by Guyuchun.

Nanjing Yodebang Medical Paclitaxel-Coated Coronary Balloon Dilation Catheter Officially Approved

Recently, the paclitaxel-coated coronary balloon dilation catheter independently developed by Nanjing Youdebang Medical Technology Co., Ltd. has officially obtained the medical device registration certificate (Registration No. 20243031552) issued by the National Medical Products Administration (NMPA).

Paclitaxel-Coated Coronary Balloon Dilatation Catheter Uses Second-Generation Non-Ionic Contrast Agent as a Drug Carrier Matrix, Focusing on Small Vessel Lesions; With Advanced Drug Coating Technology and "Fine Crystal Reinforcement" Spray Process, It Can Effectively Inhibit Intimal Hyperplasia While Dilating the Vessel, Reducing the Risk of Restenosis, Providing a Safer and More Effective Treatment Option for Patients with Coronary Heart Disease.

Market Investment and Financing Review

HeartSharp Medical Completes A+ Round Financing

Recently, Suzhou Xinrui Medical Technology Co., Ltd. ("Xinrui Medical" for short) announced the completion of its A+ round of financing. The amount of financing has not been disclosed yet, and the investor is Huaying Investment. This round of financing will be used to accelerate Xinrui Medical's product development and market promotion to better serve patients with valvular heart disease.

CardioEdge Medical was founded on December 27, 2021, as the first innovative enterprise in China dedicated to the research and development of polymer heart valves. The company focuses on cutting-edge areas of heart valve disease treatment, guided by the principles of minimally invasive surgery and interventional therapy. Through independent research and development, as well as industry-academia-clinical collaborations, it continuously builds a robust product pipeline, establishes competitive market advantages, provides systematic solutions, and supports healthcare professionals in delivering high-quality medical services to patients.

Puju Biotech Announces Completion of RMB Tens of Millions in Series A Financing

Recently, Suzhou Pujubio Biotechnology Co., Ltd. ("Pujubio") completed its Series A financing of tens of millions of yuan invested by Mifang Health Fund. Tunan Capital served as the exclusive financial advisor, and after the financing, the company successfully completed the enrollment and follow-up work for its registered clinical trial as scheduled.

Puju Biotech is a developer of biomaterials for soft tissue regeneration, focusing on building an engineering platform for bioactive filling materials. It is committed to continuously launching globally leading high-end regenerative medical material products to benefit a wide range of beauty seekers and provide new material solutions for medical aesthetics and anti-aging across all age groups.

Tianjin Zhipu Completes Tens of Millions of Yuan in Pre-A Round Financing

Recently, Tianjin Zhipu Instrument Co., Ltd. (hereinafter referred to as "Tianjin Zhipu"), announced the successful completion of a Pre-A round of financing worth tens of millions of yuan. This round of financing was led by Beiyang Haitang Fund, with follow-up investments from Haihe Industrial Fund, iFlytek Ventures, Jiuan Medical, and Binhai Industrial Fund, among other well-known investment institutions.

The funds from this round of financing will be mainly used for the serialization of high-end mass spectrometry instruments, the independent research and development of fully automated intelligent medical mass spectrometry platforms, the integration of mass spectrometry with artificial intelligence technology, and the market expansion of already listed products. This will not only drive Tianjin Zhipu to further advance in technological innovation but also assist the company in achieving a qualitative leap in new commercial layouts.

Editor: Cheng Lin