Junlin Healthcare Enterprise Development Update · Issue 9, 2024

Innovent Bio IBI363 Obtained

FDA Fast Track Designation in the United States

Treatment of Melanoma

SAN FRANCISCO, U.S. and SUZHOU, China, September 4, 2024 – Innovent Bio (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune disorders, metabolic diseases, and ophthalmology, announced that its PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). The proposed indication is for locally advanced or metastatic melanoma (excluding uveal melanoma) that has progressed following at least one prior line of systemic treatment containing a PD-1/L1 checkpoint inhibitor. Currently, Innovent Bio is conducting Phase 1/2 clinical trials in China, the U.S., and Australia to explore the efficacy and safety of IBI363 in various advanced malignant tumors.

RapidGen Therapeutics Based on Non-Viral Vectors

In Vivo Gene Editing Drug ART001

Granted FDA Clinical Trial Approval in the United States

ART001, a product independently developed by RuiZheng Gene (Suzhou) Co., Ltd. for treating transthyretin amyloidosis (ATTR), has recently received approval for its U.S. IND application, becoming the first non-viral vector-based in vivo gene editing drug produced in China to obtain clinical trial authorization from the U.S. FDA. ART001 is also the first non-viral vector-based in vivo gene editing drug in China to enter human clinical trials (IIT) and is currently undergoing Phase 1 clinical trials in China. With this U.S. FDA IND approval, ART001 has become the only drug of its kind worldwide to receive clinical trial authorization in both China and the United States. In June 2024, RuiZheng Gene presented the 24-week clinical research data of ART001 at the 2024 International BIO Convention (BIO 2024) held in San Diego, USA. The results showed that peripheral TTR protein levels in the high-dose group decreased by over 90% on average from baseline after 4 weeks of treatment and remained stable through week 24. To date, all subjects have been followed up for 36 weeks or more, with the drug’s efficacy still maintaining stability. Based on publicly available information, ART001 is currently the only in vivo gene editing product in China that achieves a 90% TTR knockdown.

Ribo Life Science's Independent Research and Development

Small Nucleic Acid Drugs for the Treatment of IgA Nephropathy

First Clinical Trial Application Approved by the EU

Recently, Suzhou Ribo Life Science Co., Ltd.'s independently developed siRNA drug RBD7007 targeting C5 has been granted clinical trial approval by the EU and will initiate its first-in-human clinical trial in Sweden. RBD7007 is an siRNA drug targeting C5 independently developed by Ribo Life Science based on the RIBO-GalSTARTM liver-targeting technology platform. It inhibits the expression of the C5 protein and blocks the activation of the complement pathway to achieve its therapeutic effect on complement-mediated diseases. Preclinical trial data show that RBD7007 has a long-lasting and potent inhibitory effect on complement pathway activation while also demonstrating good safety. It is expected to bring significant therapeutic benefits to patients with IgA nephropathy and other complement-mediated diseases. Ribo Life Science has multiple siRNA drugs based on RIBO-GalSTARTM that have entered the clinical stage, covering disease areas including cardiometabolic, liver, and immune diseases. Ribo Life Science will continue to deepen its expertise and provide patients with more innovative siRNA drugs.

YL201 Clinical Data Debut by Yilian Bio

Small Cell Lung Cancer PFS Over 6 Months

And Show Multi-Tumor Potential

On September 13, 2024, Yilian Biologics announced the clinical data of its YL201 project at the 2024 European Society for Medical Oncology (ESMO) Congress. YL201 is an ADC targeting B7H3, developed based on Yilian Biologics' TMALIN® platform. This report marks the first public disclosure of YL201’s clinical data. The Phase I dose escalation and expansion data for YL201 showed encouraging anti-tumor effects across various solid tumors, including small cell lung cancer (SCLC), nasopharyngeal carcinoma, and wild-type non-small cell lung cancer (NSCLC). In the ES-SCLC expansion cohort, the ORR was 68.1%, with an mPFS of 6.2 months. Dr. Qin Xuke, Chief Medical Officer of Yilian Biologics, stated, “Data accumulated from over 300 patients robustly demonstrate the anti-tumor efficacy of the YL201 project across multiple solid tumor types, especially in small cell lung cancer, nasopharyngeal carcinoma, and wild-type non-small cell lung cancer. Compared to existing standard treatments, YL201 shows significant improvement while maintaining a favorable safety profile that is well tolerated. We are preparing for Phase III clinical trials for indications such as small cell lung cancer and nasopharyngeal carcinoma.”

Changde Medical®EF-Lumber®

First Patient Enrolled in Peripheral Drug-Eluting Stent Clinical Trial

Recently, Shanghai Changde Medical Technology Co., Ltd. (hereinafter referred to as "Changde Medical®") has officially launched the EF-Lumber® – Peripheral Drug-Eluting Stent clinical trial, with the first patient enrolled by Professor Xiangchen Dai and his team from Tianjin Medical University General Hospital. The EF-Lumber® Peripheral Drug-Eluting Stent, a self-developed product of Changde Medical®, is designed with full consideration of the anatomical characteristics of the femoropopliteal arteries. It features a closed-loop structure at the proximal end to enhance support and improve positioning accuracy, while the distal end adopts an open-loop structure to accommodate the complex vascular conditions of the femoropopliteal arteries. The drug coating consists of paclitaxel and highly biocompatible fluorinated compounds, utilizing the sustained-release properties of fluorides to achieve long-term therapeutic effects with a lower drug load. Additionally, the stent employs a unique spray-coating technology to achieve gradient drug loading, thereby enabling targeted drug delivery and precise treatment. The delivery system incorporates an innovative four-axis design, enhancing overall stability and support to better address complex and tortuous lesions. Changde Medical® has established a comprehensive product portfolio in the field of interventional treatment for lower extremity arterial stenosis, including the EF-Rhine® Constrained Balloon Dilation Catheter, which has been commercially available in China and applied in clinical practice, and the EF-Yangtze® Below-the-Knee Rapamycin Drug-Coated Balloon Catheter, which has completed patient enrollment for pre-market clinical trials. The initiation of the EF-Lumber® Peripheral Drug-Eluting Stent clinical trial marks the company’s continued innovation and progress in this therapeutic area.

Stellar Sea Medical

Three disposable endoscope products

Obtained CE-MDR Certification

Three Cutting-edge Disposable Digital Endoscopes from StarSea Medical Receive CE-MDR Certification: LoopView® Single-Use Bronchoscopy Imaging Catheter, BubbleView® Single-Use Electronic Cystoureteroscope, and SeleneView® Single-Use Electronic Hysteroscope. This achievement highlights StarSea Medical's relentless pursuit of innovation and quality in the healthcare industry. Established in October 2020 and headquartered in Nantai Cloud Creation Valley, Guangming District, Shenzhen, StarSea Medical is an innovative medical technology enterprise specializing in single-use endoscopic interventional diagnosis and treatment, integrating R&D, production, sales, and service. Its product portfolio covers urology, ICU, gynecology, emergency, and anesthesia. The founding team of StarSea Medical comes from leading domestic and international medical device companies, with over a decade of extensive experience in endoscopic product development, global marketing, and production management.

Liget Products Approved for Multi-Country Registration

Pave New Roads for the International Market

Ligetech Obtains MDA Certification in Malaysia, INVIMA Certification in Colombia, and DIGEMID Certification in Peru. These certifications enable the sales of Ligetech’s products in the Malaysian, Colombian, and Peruvian markets, including its implants and consumables series for sports medicine surgical treatments. This marks a milestone step for Ligetech in comprehensively expanding into international markets. Shanghai Ligetech Biotechnology Group is a group company specializing in the innovative research, manufacturing, and sales of medical devices in the field of sports medicine. Adhering to the vision of becoming “the leader of China-produced sports medicine,” the company has never ceased its innovative efforts, committing itself to creating medical products of leading domestic standards to help Chinese patients recover their motor functions faster and return to normal life. With a registered capital exceeding 50 million yuan, the company operates several parallel product development pipelines based on different technological platforms, all established by multidisciplinary technical professionals and completed in collaboration with experts from key sports medicine departments and prominent universities. Its main products include artificial ligaments, cross ligament fixation systems, suture anchors, non-absorbable sutures, arthroscopic shaving systems, surgical traction frames, and other full-series sports medicine products. These products have successively obtained professional certifications such as CE, ISO13485, and NMPA. By the end of March 2023, the company's latest artificial ligament product was the first in China to obtain a medical device product registration certificate in this field, filling the domestic gap in this category of medical products.

Kaili Medical New Touch-Screen Insulin Pump

Approved by NMPA

Recently, CareLink Medical Technology (Shanghai) Co., Ltd. announced that its independently developed all-new touch-screen insulin pump successfully obtained the NMPA registration certificate on August 23, 2024. This news marks a new step forward in China’s diabetes treatment equipment field, breaking the monopoly of touch-screen insulin pump technology previously held by American companies. The minimum basal rate of CareLink's newly launched full-touch insulin pump has reached 0.01U/hour, setting a new standard in precise infusion technology and providing doctors with more accurate tools to help patients with brittle blood glucose and young diabetics achieve their control goals. The newly approved full-touch insulin pump adopts advanced Bluetooth communication technology, enabling better transmission and management of device data. Combined with CareLink Medical's cloud data management technology, which has been independently developed over the past decade, this innovation further applies the concept of intelligent chronic disease management into practice.

King's Medical First ProductBased on Reversible Terminator Technology

Sequencing-based SARS-CoV-2 Detection Kit

And the software officially received Class III registration approval.

Recently, the "2019-nCoV Nucleic Acid Detection Kit (Reversible Terminator Sequencing Method)" and the "2019-nCoV Sequencing Data Analysis Software," independently developed by KeySight Medicine, have been approved for marketing by the National Medical Products Administration. Their registration certificate numbers are Guxie Zhun 20243401661 and Guxie Zhun 20243211580, respectively. KeySight Medicine's newly approved products represent the only 2019-nCoV detection kit compatible with the reversible terminator sequencing platform currently available, as well as the only pathogen detection kit on this platform to date. The approval and market launch of this kit and software can be used for the first-time registration and modification registration applications for pathogen detection using next-generation sequencers based on the principle of reversible terminator sequencing. This addresses a key industry pain point: the lack of compatible, commercially available kits during the application process for reversible terminator sequencing-based next-generation sequencers.

Tongxin Zhiyi Partners with Tiantan Hospital

Approved by the National Science and Technology Innovation 2030 "Chinese Population Intracranial

"Comprehensive Intelligent Diagnosis and Treatment System for Aneurysms" Major Project

Recently, the立项results of the Major Project of the Ministry of Science and Technology's Scientific and Technological Innovation 2030 — "Research on the Prevention and Treatment of Cancer, Cardiovascular, Respiratory, and Metabolic Diseases" have been officially announced. Dr. Chen Xiaolin, Administrative Deputy Chief of the First Ward of Cerebrovascular Disease in the Neurosurgery Department at Beijing Tiantan Hospital (National Clinical Research Center for Neurological Diseases), Capital Medical University, has participated as a project leader in the "Comprehensive Intelligent Diagnosis and Treatment System Establishment for Intracranial Aneurysms in the Chinese Population," led by Huashan Hospital Affiliated to Fudan University (National Medical Center for Neurological Diseases), Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, the Second Affiliated Hospital of Zhejiang University School of Medicine, and the First Affiliated Hospital of Fujian Medical University. This project has been approved for立项. Additionally, Tongxin Zhiyi Technology (Beijing) Co., Ltd., a high-tech enterprise specializing in artificial intelligence for major brain diseases based on clinical needs, is honored to participate in this national-level major project. Relying on its powerful self-developed next-generation artificial intelligence algorithms that adhere to evidence-based medicine, Tongxin Zhiyi is collaborating with Tiantan Hospital to build a comprehensive, precise, and intelligent diagnosis and treatment system. The aim is to achieve early screening, accurate diagnosis, personalized treatment, and long-term management of intracranial aneurysms in the Chinese population, while providing decision support for doctors.

Lingfu Bio "Biopharmaceutical Transformation ResearchAnd

Evaluation of Non-Human Primate Innovative Models

Joint Laboratory Inaugurated

On September 20, the unveiling ceremony of the "Joint Laboratory for Biopharmaceutical Translation Research and Non-Human Primate Innovative Model Evaluation" was held at the Process Building. The Joint Laboratory, established by the State Key Laboratory of Biochemical Engineering (Key Laboratory of Biopharmaceutical Preparation and Delivery) of the Institute of Process Engineering, Chinese Academy of Sciences, and Beijing Lingfu Biotechnology Co., Ltd., is dedicated to creating a comprehensive scientific research platform that integrates biopharmaceutical translation research and non-human primate innovative model evaluation. It aims to bridge the gap between biopharmaceutical research and clinical translation, filling in the critical missing links between basic biopharmaceutical research and clinical application. Through this platform, we can accelerate the effective transformation of biopharmaceuticals from fundamental scientific research achievements into the health industry, opening a new chapter in China's biopharmaceutical development.

Taikun PharmaceuticalsU.S. Clinical Supply Center Completes Expansion

Enhance Clinical Supply Management and Service Capabilities

Recently, as the second overseas marketing-supported clinical supply center of Taikun Pharma, the Taikun Pharma U.S. Clinical Supply Center plays a crucial role in Taikun's global strategy. To further enhance local service capabilities and provide more comprehensive clinical management solutions for clients in North America and Central/South America, the Taikun U.S. Clinical Supply Center has added a -20℃ cold storage facility and expanded its capacity for low-temperature secondary packaging based on existing infrastructure. This upgrade by Taikun U.S. aims to meet the increasingly diversified needs of clinical supply services, helping more biopharmaceutical clinical studies achieve international multi-center trial planning. In the future, Taikun Pharma will continue to invest in and expand the facilities and service capabilities of its U.S. Clinical Supply Center to offer reliable, flexible, and integrated support to clients in North America.

Baiyang Partners with Fuwai Hospital

Joint Research and Development Center

Focus on the Transformation of Innovative Achievements in the Cardiovascular Field

On September 1, 2024, the "China Heart Congress Innovation and Transformation Forum and Jingxi Innovative Pharmaceutical and Device Industry Development Conference" was grandly held in Beijing. During the conference, Baiyang Pharmaceutical Group and Fuwai Hospital of the Chinese Academy of Medical Sciences held a signing ceremony. The two parties will establish the "Fuwai Hospital-Baiyang Pharmaceutical Myocardial Repair and Regeneration Drug Joint Research and Development Center" to jointly explore new models for the prevention and treatment of cardiovascular diseases, promote the transformation and application of high-quality scientific research achievements, and benefit patients. Through the establishment of this joint R&D center, Baiyang Pharmaceutical Group and Fuwai Hospital will, based on the shared vision of enhancing the level of cardiovascular disease prevention and treatment in China, leverage Fuwai Hospital's clinical resources and scientific research capabilities as well as Baiyang’s advantages in incubating and industrializing pharmaceutical innovations, to jointly advance the R&D and transformation of myocardial repair and regeneration drugs, promote efficient collaboration between basic research and clinical applications, and provide safer and more effective treatment options for cardiovascular disease patients.

BioMap collaborates with Dabeinong

Jointly Building a Large Agricultural Biotechnology AI Scenario Model

Build Zhongguan Village Biological Manufacturing Innovation Center

On September 10, 2024, BioMap and Dabeinong reached a strategic cooperation. By combining BioMap's xTrimo, a life science large model with billions of parameters, and Dabeinong's application scenario advantages in the field of large agricultural biotechnology, the two parties will jointly build a large AI model for agricultural biotechnology and create the Zhongguancun Bio-Manufacturing Innovation Center, focusing on directions such as biosynthesis, gene editing, proteomics, pharmaceutical health, and artificial intelligence+. BioMap and Dabeinong will join forces to build a large agricultural biotechnology innovation ecosystem, empowering global bio-manufacturing ecological chain projects and achieving a commercial closed loop in R&D, pilot testing, scaling, and industrialization in the fields of AI models for large agriculture and AI protein design. Based on leading AI model construction and biotechnology, BioMap will assist Dabeinong in building its own AI model and an automated high-throughput dry-wet closed-loop AI bio-manufacturing platform, empowering technological innovation in the field of large agricultural biotechnology. The cooperation between the two parties will have a significant impact on the development of the bio-manufacturing industry.

iFlytek Medical and Boyin Hearing Strategic Cooperation

Create a New O2O Hearing Aid Fitting Service Model

On September 12, iFlytek Healthcare, a subsidiary of iFlytek, signed a strategic cooperation framework agreement with Boyin Hearing at the headquarters of Boyin Hearing in Shanghai. Both parties innovated together to launch an O2O hearing aid fitting solution—aimed at addressing the common fitting challenges faced amid the rising trend of online hearing aid purchases. Through in-depth collaboration, they strive to resolve practical issues for individuals with hearing loss and provide a seamless new experience in hearing aid fitting services. iFlytek Healthcare and Boyin Hearing jointly introduced an "online selection, offline fitting" O2O innovative service model. After users select their desired iFlytek hearing aids on the online platform, they can easily book professional fitting services from Boyin Hearing. Across China, Boyin Hearing has numerous direct operation systems—with the first batch of pilot locations including over 30 sites in Beijing, Shanghai, Sichuan, Chongqing, Shandong, Guizhou, and more—offering users convenient offline fitting services.

Innovent Bio Partners with Strategic Collaborator Kaili Medical

Jointly Open a New Chapter in Diabetes Management

Embecta Corp (NASDAQ: EMBC), a global diabetes care company with a 100-year history in insulin infusion, officially announced that it has signed an agreement with CareLink Medical Technology (Shanghai) Co., Ltd. ("CareLink Medical"). According to the agreement, the two parties reached an exclusive cooperation in August 2024 for the customer promotion of CareLink Medical's Yope Pump® and Ray Pump® insulin pumps in mainland China. The exclusive collaboration models of CareLink Medical-Embecta, Yope Pump® and Ray Pump®, are the new-generation fully touch-controlled insulin pumps that received approval from the National Medical Products Administration on August 23, 2024. CareLink Medical is a digital and intelligent medical technology enterprise focusing on innovative applications of micro-dose drug delivery technology. Over the past decade since its establishment, the company has successively launched products such as insulin pumps, pituitary hormone pumps, and electronic smart insulin pens, advocating and realizing a new model of diabetes cloud management based on digital and intelligent insulin pumps.

Legend Capital's Multiple Healthcare Portfolio Companies

Awarded the National-Level Specialized and Innovative Title

Recently, the Ministry of Industry and Information Technology announced the sixth batch of national "Little Giant" enterprises specializing in specialized, refined, distinctive, and innovative development. Several medical portfolio companies of Legend Capital have been honored with the national title of specialized and innovative "Little Giant." These "Little Giant" enterprises represent the highest level in the tiered cultivation of small and medium-sized enterprises (SMEs), acting as pioneers among high-quality SMEs. They are situated in core areas of industrial foundations and key links of the industrial chain, demonstrating outstanding innovation capabilities, mastery of core technologies, high market share in niche markets, and excellent quality and efficiency, forming the core strength of high-quality SMEs.

· MindLinker

· JianGeng Medicine

· Haihe Pharmaceutical

· Ligetai

· Shanghai Cell Therapy Group

·Yeasen Biotech

· Jin Qi Rui

· Dingkang Medical

· Lianya Pharma

·Haiskell

· Gloria Health

· BioRay

· Raylife

· Zhongsheng溯源

·Dentaphi

· Hanchen Lightwing

· Ruiqi Surgical

HaiLai Innovation, ZhiXiang Bio

Selected as a Unicorn Enterprise in Jiangsu

Recently, the Jiangsu Productivity Promotion Center released the 2024 Jiangsu Unicorn Enterprise List.

A total of 12 companies in Wuxi made the list, with Hila Innovation successfully selected due to its forward-looking technological innovation capabilities and strong development momentum. It has become the first company in Huishan District and one of only two listed enterprises. Unicorn companies, as typical representatives of new quality productivity, are a powerful engine driving regional economic transformation, upgrading, and innovative development. Established in 2016, Hila Innovation focuses on the industrialization of domestically produced innovative Class III medical devices and is the first company in China to introduce domestically produced tumor treatment electric field technology into multi-center clinical research.

Intelligent Sharing Bio Honored as Provincial Unicorn Enterprise, One of Five Unicorn Companies Selected in Changshu City. Intelligent Sharing Bio was established in 2018, focusing on the CDMO field of large molecule biopharmaceutical process development and large-scale commercial production. Since its inception, it has been committed to "assisting clients in pharmaceuticals, achieving a healthy life," providing one-stop outsourcing services for global biotechnology and biopharmaceutical companies, including process development, quality control and testing, clinical and commercial GMP production, and registration applications for large molecule biologics such as monoclonal antibodies, antibody-drug conjugates (ADC), and recombinant proteins. Within six years, it has completed the construction of three major production bases. It is one of the few CDMO enterprises in China with proprietary cell lines, proprietary chemically defined component culture media, core technology, scaled production capacity, and comprehensive commercial closed-loop capabilities.

Tianxing Medical

Awarded the 2024 Beijing Top 100 Private SMEs

On September 26, the Beijing Federation of Industry and Commerce and the Tongzhou District People's Government jointly held the 2024 Beijing Private Enterprises Top 100 "1+4" List Release Conference. Beijing Tianxing Medical Co., Ltd. was ranked 22nd in the 2024 Beijing Small and Medium-sized Private Enterprises Top 100. The ranking of Beijing’s small and medium-sized private enterprises is based on the classification standards for enterprise size outlined in the "Regulations on the Classification Standards for Small and Medium Enterprises" (MIIT Joint Enterprise [2011] No. 300). It evaluates companies based on core indicators such as their 2023 operating performance, industrial development positioning, years of industry experience, and R&D innovation capabilities, while also comprehensively considering compliance with laws and regulations, integrity, and other aspects. Enterprises are selected for the list based on the quantified scoring of core and auxiliary indicators. As a leading company in China’s sports medicine industry, Tianxing Medical has nine sports medicine products that were the first domestically produced to receive approval from the National Medical Products Administration (NMPA) for marketing. These include the PEEK screw-sheath fixation system, PEEK suture anchors, absorbable interface screws, absorbable suture anchors, absorbable screw-sheath interface fixation systems, and all-suture anchors. The company's products have been introduced into more than 500 tertiary hospitals and above, establishing an extensive marketing network.

Cloud Boat Bio

Selected for the "Top 100 List of High-Productivity Enterprises with New Quality in Guangzhou 2024"

Recently, the 2024 China Innovation and Entrepreneurship Achievements Trade Fair was successfully held in Guangzhou, during which the "Top 100 List of Guangzhou's New Quality Productivity High-Tech Enterprises" was grandly announced. GenScript Biotech, with its outstanding innovation capabilities, excellent market performance, and remarkable growth, successfully made it onto the top 100 list. As a leading enterprise in the field of gene delivery, GenScript Biotech always drives its development through innovation, committed to providing high-quality and efficient gene delivery products and services to customers worldwide. The company’s self-developed online gene vector design and ordering platform, VectorBuilder (VectorBuilder), has revolutionized the traditional method of DIY vector construction in laboratories, ushering in an era of commercialized custom gene vectors. Through continuous innovation, GenScript Biotech has received numerous honors, including "National High-Tech Enterprise," "National Specialized, Refined, Unique, and Innovative 'Little Giant' Enterprise," "Guangdong Province Technologically Advanced Service Enterprise," "Guangdong Province Intellectual Property Demonstration Enterprise," "First Prize in the 2022 China Innovation and Entrepreneurship Competition," and "First Prize in the National Enterprise Group of the 2022 Maker China Competition." In both 2022 and 2023, GenScript Biotech was consecutively listed on the "Top 100 List of Guangzhou's Proposed Listed High-Tech Enterprises."

Ansukang Medical HonoredMedical EquipmentSmall and Medium Enterprises

Second Prize in the Finals of the Innovation and Entrepreneurship Competition

Ranked among the top 5 in China

On September 13, 2024, in strong response to China's deepening healthcare reform goals, Ansucon Medical participated in the 9th "Maker China" Medical Equipment SME Innovation and Entrepreneurship Competition with its star product, the "New Generation Host-Free Ultrasonic Scalpel." After rounds of selection and competition, the project won second prize in the finals, ranking among the top 5 in China, thanks to its iterative innovative design, fully independent intellectual property rights, and significant end-user benefits. The "New Generation Host-Free Ultrasonic Scalpel" was not only the only ultrasonic scalpel category project to enter the finals in this competition but also the only one in the history of the competition.