Two Innovative Medical Devices Approved; Bromhexine Hydrochloride Injection Removed from National Volume-Based Procurement; Johnson & Johnson Finalizes Acquisition of V-Wave; Innovent’s Fuzeleresib Tablets Conditionally Approved

Aug 26, 2024 17:31 CST Updated 17:31

Johnson & Johnson

Medical Device R&D and Manufacturer

V-Wave

Developer of Percutaneous Implantable Devices

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Medicine Valley·一Weekly News

Overview of Major Policies

1, Bromhexine Hydrochloride Injection National Centralized Procurement Canceled

On August 21, the National Joint Procurement Office for Medicines officially announced penalties for bid-rigging and collusive bidding in the national procurement of Bromhexine Hydrochloride Injection. After collective deliberation by all member units of the National Joint Procurement Office for Medicines, it was decided to revoke the winning qualifications of four original winning companies—Chengdu Xinjie, Renhe Yikang, Guangzhou Pinred, and Shijiazhuang Fourth Pharmaceutical—for Bromhexine Hydrochloride Injection. These four companies, along with two non-winning enterprises—Shanghai Xudong Haipu and Jiangxi Yiyou—have been placed on a "list of violations." The participation of Renhe Yikang, Guangzhou Pinred, and Shijiazhuang Fourth Pharmaceutical in the national centralized drug procurement will be suspended from August 21, 2024, to February 20, 2025 (6 months). For Chengdu Xinjie, Shanghai Xudong Haipu, and Jiangxi Yiyou, their participation will be suspended from August 21, 2024, to August 20, 2025 (12 months). The seventh batch of national centralized procurement for Bromhexine Hydrochloride Injection has been declared void, and regions across China will manage it as a non-centralized procurement product to ensure clinical supply.

2. The Department of Regulations of the National Health Commission released the mandatory health industry standard "Standard for Anesthesia Records (WS 329-2024 replacing WS 329—2011)" and the recommended health industry standards "Standard for Medical Institution Symbols (WS/T 307-2024 replacing WS 307—2009)", "Technical Protocol for Medical X-ray Examination Operations (WS/T 389 -2024 replacing WS/T 389—2012)", "Technical Protocol for CT Examination Operations (WS/T 391-2024 replacing WS/T 391—2012)", "Technical Guidelines for Performance Assurance of Positron Emission and X-ray Computed Tomography Systems (PET/CT) (WS/T 837-2024)", "Training Standards for Pre-hospital Emergency Medical Care for Healthcare Professionals (WS/T 839-2024)", "Standards for Infection Control Management in Dental Clinics (WS/T 842-2024)", "Standards for Setting up Geriatric Palliative Care Wards (WS/T 844-2024)".Standard for Bed Transfer Between Elderly Care and Medical Areas in Integrated Medical and Elderly Care Institutions (WS/T 845-2024)

3、CDE Releases "Guiding Principles for Clinical Virology Research and Data Submission of Anti-HIV-1 Infection Drugs (Draft for Comments)"

4. Beijing Municipal Health Commission, Tianjin Municipal Health Commission, and Hebei Provincial Health Commission Jointly Issue the "Graded Management Directory for Clinical Application of Antimicrobial Drugs in Medical Institutions in the Beijing-Tianjin-Hebei Region (2024 Edition)"

This directory will be implemented as of the date of issuance of this notice."The Beijing Antibacterial Drug Clinical Application Classification Management Directory (2023 Edition)", "The Tianjin Antibacterial Drug Clinical Application Classification Management Directory (2021 Edition)", and "The Hebei Antibacterial Drug Clinical Application Classification Management Directory (2012 Edition)" are hereby repealed.The specific graded management implementation measures shall be formulated separately by the three regions in accordance with their respective actual conditions.The health commissions of the three regions will adjust and update the catalog as appropriate based on the situation. Referring to previous management requirements and methods.，In principle, antimicrobial drugs not included in the catalog are not recommended for use.

Major Industry Events

1、Public DiscoveryAnti-TF ADCDrug "Going Overseas”

Puzhong Discovery and Adcendo jointly announced that they have reached a licensing agreement for ADCE-T02 (Puzhong Discovery’s research and development code: AMT-754), a novel, highly differentiated antibody-drug conjugate (ADC) targeting tissue factor (Anti-TF). Adcendo will obtain exclusive global development and commercialization rights outside of Greater China, while Puzhong Discovery will retain the development and commercialization rights in Greater China (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan region).

According to the financial terms of the agreement, Publink Discovery will receive an upfront payment worth tens of millions of US dollars. Upon achieving subsequent development, regulatory, and commercial milestones, it will be entitled to receive total milestone payments exceeding 1 billion US dollars, along with tiered royalties in the single-digit to low double-digit percentages based on global net sales (excluding Greater China).

Tissue Factor (TF) is overexpressed in bladder cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, esophageal cancer, head and neck cancer, and gastrointestinal cancer, but its expression is restricted in normal tissues, making it an excellent ADC target.

The press release shows that ADCE-T02 is a novel, highly differentiated Anti-TF ADC. Its unique antibody design can reduce the impact on the coagulation pathway. Meanwhile, the T1000-exatecan linker-payload technology platform has been proven by research to amplify the "bystander effect," enhance linker stability, and possess the potential to overcome drug resistance mechanisms. ADCE-T02 has been submitted for clinical trial approval in Australia and is expected to file for U.S. IND approval in the near future.

Pharmaceuticals and Medical Devices Approved in China

1. Innovative Product Venous Stent System Approved for Marketing

The National Medical Products Administration has approved the innovative product registration application for the "Venous Stent System" by Shanghai Lanmai Medical Technology Co., Ltd. The product consists of a venous stent and delivery system, intended for use in the iliac and femoral veins to treat non-thrombotic iliac vein compression syndrome, deep vein thrombosis, and post-thrombotic syndrome. The stent employs an integrated weaving method with varying mesh densities; the combination of dense and sparse mesh effectively meets clinical requirements for both stent support and flexibility.

2. Innovative Product Transcatheter Aortic Valve System Approved for Marketing

The National Medical Products Administration has approved the innovative product registration application for the "Transcatheter Aortic Valve System" submitted by Beijing Balloon Medical Technology Co., Ltd. The product consists of a bioprosthetic valve, delivery system, balloon-expandable catheter, catheter sheath kit, crimping device, and inflation pump. Featuring a balloon-expandable stent structure, it is suitable for patients aged 70 years or older with symptomatic, calcified, severe degenerative native aortic valve stenosis who are deemed unsuitable for conventional surgical valve replacement after evaluation by a cardiac team using a scoring system. Under the monitoring of medical imaging equipment, the bioprosthetic valve can be selectively implanted into the patient’s aortic annulus via either long or short delivery systems through different access routes, replacing the diseased aortic valve, alleviating the narrowing at the affected site, improving cardiac function, and meeting clinical needs of patients with varying access routes.

3. China's National Medical Products Administration Granted Conditional Approval for the Marketing of Fluocinolone Acetonide Implant

China's National Medical Products Administration (NMPA) has conditionally approved the marketing of Innovent Biologics, Inc.'s innovative Class 1 drug Fuzelresib Tablets (brand name: Dabot) through the priority review and approval process. This medication is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring the mouse sarcoma virus oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy.

4. The World's First Long-Acting Growth Hormone Product for Turner Syndrome Approved

Changchun Jin Sai Pharmaceutical Co., Ltd. announced that the new specification and new indication of its Polyethylene Glycol Recombinant Human Growth Hormone Injection (trade name: Jin Sai Zeng) have been approved by the National Medical Products Administration. The newly approved specification is 27IU/4.5mg/0.5ml/bottle, which can be used for growth disorders in girls caused by gonadal dysplasia (Turner syndrome). According to the information on the official website of Jin Sai Pharmaceutical, this is also the world's first long-acting growth hormone product approved for this indication.

5. Astellas' Nectin-4 Targeted ADC Drug Approved

Astellas' Nectin-4-targeted ADC drug, Vedotin Monoclonal Antibody for Injection, has been approved for marketing. The drug is used to treat adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have previously received platinum-based chemotherapy and programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitor therapy.

6. Boston Scientific's 3T MRI-Compatible Implantable Cardiac Resynchronization Therapy Defibrillator Approved for Marketing by China's National Medical Products Administration

Overseas Highlights

1. Johnson & Johnson Announces Final Agreement to Acquire V-Wave

On August 20, Johnson & Johnson announced that it had reached a definitive acquisition agreement with V-Wave Ltd. Under the agreement, Johnson & Johnson will acquire V-Wave for an upfront payment of $600 million (approximately RMB 4.3 billion), subject to customary adjustments, with the potential for up to approximately $1.1 billion in additional regulatory and commercial milestone payments. As a result, the total transaction value could be approximately $1.7 billion (approximately RMB 12.1 billion). The transaction is expected to be completed by the end of 2024, subject to applicable regulatory approvals and other customary closing conditions.

In the past two years, Johnson & Johnson has been continuously increasing its investment in the cardiovascular field. Previously, Johnson & Johnson acquired Abiomed, the leader in artificial heart technology, as well as Shockwave, a company specializing in cardiovascular interventions.

V-Wave, established in 2009, focuses on developing percutaneous implantation technology for patients with chronic heart failure. Its core product is the Ventura Interatrial Shunt. Heart failure, a common cardiovascular disease, has seen significant treatment advancements over the years. However, the incidence and mortality rates of left-sided heart failure remain high. In chronic heart failure patients, elevated left atrial pressure leading to pulmonary congestion is a common mechanism behind symptom deterioration and acute decompensation. Recently, interatrial shunting has emerged as a novel therapy for heart failure, gaining industry attention. Reportedly, interatrial shunting can reduce pressure through diversion, alleviate excessive left atrial volume, improve symptoms caused by heart failure, and enhance patient quality of life, representing a new minimally invasive interventional treatment. However, this technology remains highly controversial, with many believing it offers limited clinical benefits. Currently, several innovative medical device companies worldwide are developing various interatrial shunting technologies, but no such product has yet received FDA approval. Among them, Corvia Medical, supported by Edwards Lifesciences, and V-Wave Ltd., recently acquired by Johnson & Johnson, are the front-runners.

Investment and Financing Moment

1. Sichuan Xinyuan Bio Completes Pre-A Round Financing Worth Tens of Millions of Yuan

This round of financing was led by Pine Healthcare Fund, and the funds will be used for the research and development and market promotion of the company's perioperative brain function monitoring products and a new generation of neuromodulation products. The company was founded in 2014, and in September 2023, the SR1 EEG acquisition device obtained Class II medical device registration. Currently, New Source Neuroscience is collaborating with Huaxi to conduct clinical research on intraoperative brain function monitoring products, accumulating thousands of hours of intraoperative multimodal brain function data, with plans to achieve productization by the end of 2024.

2. V-Wave Medical Completes Nearly RMB100 Million Series A Financing

This round of financing was led by Tasly Capital, with Delian Capital and Tianfeng Capital following up. The companyFounded in July 2021, the company possesses a multi-modal energy platform and key technologies including pulsed electric fields, ultrasound, radiofrequency, and plasma. Currently, the world's first third-generation nanosecond pulsed field ablation (nsPFA) product for atrial fibrillation treatment has successfully completed its registration clinical trial, while another innovative product, the world’s first adjustable ultrasound renal denervation system (muRDN), is currently in the clinical trial stage.

3. Listed Company Opu-Mai Invests Tens of Millions in Haixing Bio

Opmay recently announced that it has reached a significant strategic investment agreement with Haixing Biotech. According to the agreement, Opmay invested tens of millions of yuan, becoming an important strategic partner of Haixing Biotech. Suzhou Haixing Biotech is a CRO company specializing in the research, development, production of cell culture full-scenario products and cell gene editing technical services. Through this cooperation, Haixing Biotech will leverage Opmay’s comprehensive GMP production system to upgrade the GMP production of core raw materials for cell culture, accelerating its expansion into the global market.

4. Meiliu Bio Completes Angel Round Financing

This round of financing was led by Sichuan Rongle Investment, with Hangzhou Xihu Sci-Tech Innovation Investment as a follower. Meiliu Bio uses advanced engineered strain technology and focuses on the synthetic biology field. This round of financing will mainly be used for the research and development of new products in the recombinant protein sector, product iteration, and the enhancement of marketing capabilities and brand influence both domestically and internationally.

IPO Listing

1. Tongyuan Kang Pharmaceutical officially listed on the Hong Kong Stock Exchange

On August 20, "the first deuterium drug stock in Hong Kong Stock" Tongyuan Kang Medicine (02410.HK) was officially listed.

The prospectus shows that Tongyuan Kang Medicine is a clinical-stage biopharmaceutical company dedicated to discovering, acquiring, developing, and commercializing differentiated targeted therapies to meet unmet medical needs in cancer treatment. Since its establishment in 2017, the company has built a pipeline of 11 drug candidates, including the core product TY-9591, six clinical-stage products, and four preclinical-stage products. Among them, TY-9591 is currently undergoing a pivotal Phase II clinical trial in China as a monotherapy for first-line treatment of brain metastases in epidermal growth factor receptor ("EGFR") mutant non-small cell lung cancer ("NSCLC"). Additionally, a registrational Phase III clinical trial of TY-9591 as a monotherapy is being conducted in China for the first-line treatment of locally advanced (Stage IIIb or IV) or metastatic NSCLC with EGFR L858R mutations.

In addition, in August 2020, Tongyuan Kang Medicine signed a patent transfer and exclusive technology license agreement with Livzon Medicine for the TY-2136b under research. The rights to develop, produce, and commercialize TY-2136b in Greater China were granted to Livzon Medicine. TY-2136b is a self-developed, oral ROS1/NTRK inhibitor used for the treatment of solid tumors.

The prospectus shows that in 2022 and 2023, Tongyuan Kang Medicine incurred net losses of 312 million yuan and 383 million yuan, respectively; for the three months ended March 31, 2024, Tongyuan Kang Medicine reported a net loss of 108 million yuan. Tongyuan Kang Medicine noted that the company's annual loss increased from 312 million yuan in 2022 to 383 million yuan in 2023, mainly because in 2022, payments related to TY-2136b received from Livzon Medicine were recognized as revenue, while as of December 31, 2023, the next milestone that would trigger Livzon Medicine’s payment obligation had not been reached.

The prospectus also shows that Tongyuan Kang Medicine's R&D costs for the years 2022 and 2023, as well as for the three months ended March 31, 2024, were RMB 229.8 million, RMB 249.3 million, and RMB 64.7 million, respectively. As of March 31, 2024, Tongyuan Kang Medicine's R&D team had 102 members.

In this IPO, Tongyuan Kang Medicine globally offered 47.88 million shares, with 90% for international placement and 10% for public offering. The issue price was set at HK$12.10 per share, with each lot consisting of 500 shares, raising approximately HK$579 million. The net proceeds from the IPO amounted to about HK$506.3 million, with around 70% allocated for the research, development, and commercialization of core products; approximately 20% for the R&D of other candidate products; about 3% for potential strategic acquisitions, investments, licensing, or collaboration opportunities; and roughly 7% for working capital and other general corporate purposes.

As of the closing on Friday, August 23, Tongyuan Kang Medicine closed at HK$21.60 per share, nearly doubling from the offering price.

Text | MedValley

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