Lian Capital Healthcare Portfolio Highlights – Issue 8, 2025

BCIFlex Completes Over 300 Million Yuan in Series A Financing, Building a World-Leading Next-Generation Flexible Brain-Computer Interface Platform

Recently, Beijing Bciflex Medical Technology Co., Ltd. (referred to as BCIFlex), a hard-tech innovation pioneer focusing on the development of a new generation of invasive flexible brain-computer interface platforms, announced the completion of an over 300 million yuan Series A round of financing. The funds raised in this round will mainly be used to accelerate the advancement of next-generation technology research and development and to carry out large-scale clinical trials. Since its establishment in 2022, BCIFlex has developed rapidly, with total financing reaching nearly 500 million yuan, fully reflecting the capital market's high recognition of its technical route and commercialization prospects. The BCIFlex R&D team has been deeply engaged in the field of flexible electrode materials for decades. The team’s self-developed invasive high-throughput flexible electrode has received patent authorization in both China and the United States, setting a precedent in the industry. This electrode uses ultra-thin flexible material, with micron-level thickness significantly reducing the proportion of the brain occupied and implantation damage. It has passed biocompatibility testing, and its mechanical properties match excellently with brain tissue, ensuring safe implantation. Established in 2022, BCIFlex is an innovative medical device company formed by a team of top global scientists specializing in advanced materials, micro-nano manufacturing, artificial intelligence, and neuroscience, along with an experienced corporate management team. The company is committed to developing a new generation of high-throughput flexible brain-computer interface platforms based on invasive flexible electrodes. In just over two years since its establishment, the company has been granted more than 30 patents at home and abroad, covering core technology areas of brain-computer interfaces.

Innovent Bio's IBI363 (PD-1/IL-2α-bias) Receives U.S. FDA Approval to Initiate the First Global Pivotal Phase III Clinical Trial for the Treatment of Squamous Non-Small Cell Lung Cancer

August 25, 2025, San Francisco, USA, and Suzhou, China — Innovent Bio (Stock Code: 01801.HK), a biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, announced that the Investigational New Drug (IND) application for the first global Phase III clinical study (MarsLight-11) of its self-developed world-first PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 has been approved by the U.S. Food and Drug Administration (FDA). This approval is for the treatment of patients with immune-resistant squamous non-small cell lung cancer (NSCLC), marking a significant advancement in the global development of this innovative dual-immunotherapy. The pivotal registration study in China comparing IBI363 (PD-1/IL-2α-bias) head-to-head with pembrolizumab (Keytruda®) for the treatment of melanoma is also underway. This IND approval follows positive feedback received during a recent End-of-Phase 2 (EOP2) meeting between Innovent Bio and the FDA, which confirmed the key elements of the Phase III clinical trial protocol, including dose selection, study design, and other critical aspects. Previously, the IND was also approved by China’s National Medical Products Administration (NMPA). Meanwhile, Innovent Bio is actively engaging with other major regulatory agencies worldwide. To date, IBI363 has received Breakthrough Therapy Designation (BTD) from China’s NMPA and Fast Track Designation (FTD) from the U.S. FDA for this indication.

LX107 by Longxin Bio Completes World's First Gene Therapy Administration for Adult AIPL1 Mutation-Related Inherited Retinal Dystrophy

On August 7, 2025, the National Clinical Research Center for Ocular Diseases and the Department of Ophthalmology at Shanghai First People's Hospital successfully completed the world’s first subretinal injection gene therapy administration in an adult subject with AIPL1 gene mutation-related inherited retinal dystrophy (AIPL1-IRD). As of the 12th day post-operation, the subject's systemic and ocular conditions were both stable. This clinical trial is led by Professor Sun Xiaodong, Director of the Ophthalmology Center, as the Leading PI. It is an investigator-initiated, prospective, open-label, non-randomized, dose-escalation clinical study designed to evaluate the overall safety and preliminary efficacy of a single subretinal injection of LX107 in one eye for the treatment of AIPL1-IRD. LX107, used in this trial, was independently developed by Shanghai Longsheng Biotechnology Co., Ltd. Based on an rAAV vector, it delivers the human AIPL1 gene to retinal cells using a gene supplementation strategy to restore or preserve visual function. This marks the first exploration of gene therapy for AIPL1-related genetic disorders in China, filling a gap in this field within the country.

Abogen Biosciences' mRNA Therapeutic Cancer Vaccine Approved for Clinical Trials in Both China and the U.S.

On August 4, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the investigational new drug (IND) application (acceptance number: CXSL2500388) for ABO2102, a novel mRNA cancer vaccine independently developed by Abogen Biosciences that simultaneously targets multiple KRAS mutations, has received clinical trial authorization by default. As China’s first therapeutic cancer vaccine targeting multiple KRAS mutations, ABO2102 is suitable for patients with solid tumors carrying any of the five common KRAS mutations. It represents a significant advancement in the highly challenging field of difficult-to-drug targets. ABO2102 had already received clinical trial approval from the U.S. Food and Drug Administration (FDA) this past May. This recent approval in China marks an important milestone for ABO2102, achieving dual filings and approvals in both China and the United States, fully demonstrating Abogen Biosciences' globally leading innovation capabilities and international strategic layout in the field of cancer immunotherapy.

NanoVizion's World's First Phased-Array CT Completed in Shanghai

On August 12, the world's first phased-array CT was installed at Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. This medical imaging device, fully independently developed by NanoVizion, has achieved a 64-fold increase in spatial resolution, a 3-fold increase in temporal resolution, and a 144-fold increase in the amount of information from a single scan through its new imaging technology, officially entering the clinical trial stage. The phased-array CT adopts a completely new imaging method. Cao Hongguang, Chief Scientist of NanoVizion, introduced: "The phased-array CT innovatively uses an electronic control system with a full-ring detector array and distributed X-ray source array, replacing mechanical rotation structures with precise timing pulse exposure, successfully breaking through the physical limitations that restrict CT scanning speed. With its ultra-high precision imaging capability at the micron level, this equipment raises the detection rate of early lesions to a whole new level. It not only brings revolutionary breakthroughs for ultra-early diagnosis of tumors and cardiovascular and cerebrovascular diseases but also enables precise monitoring and management throughout the entire disease course, laying a key technical foundation for precision medicine practice."

Hisky Medical's Confocal Laser Microendoscope CelTouch® Receives FDA Approval

Recently, Hisky's confocal laser microendoscope CelTouch® has been approved by the FDA as a Class II device, marking that the product's technical safety and effectiveness have reached an internationally advanced level. It is also the first market certification qualification obtained overseas for a domestically produced product of its kind. The confocal laser microendoscope CelTouch® is a breakthrough ultra-high-resolution microscopic imaging technology capable of magnifying in vivo tissue cells up to 1000 times, achieving micron-level resolution imaging, providing clinical "in vivo real-time optical pathology" images. Hisky Medical Technologies originated from Tsinghua University and owns multiple self-developed brands, including the iLivTouch® non-invasive liver detection system, CelTouch® confocal laser microendoscope, EQTouch® high-end ultrasound research platform, and breast disease diagnosis and treatment solutions, which can be applied to non-invasive screening, diagnosis, and post-diagnosis management in the fields of liver, digestive, physical examination, respiratory, breast, urology, and surgery. Hisky boasts strong R&D capabilities and has successively participated in national "The Twelfth Five-Year Plan"Science and Technology Support Plan, National"13th Five-Year Plan"Several national or provincial-level scientific and technological projects, such as the National Science and Technology Major Project and the Key Projects of Beijing Natural Science Foundation, with over 600 patent applications filed domestically and internationally. Achieved international advanced levels in advanced optical systems, advanced acoustic systems, and intelligent imaging fields. Has successively received numerous honors, including the title of 'Little Giant' enterprise specializing in new expertise awarded by the state, the Huang Jia-Shi Biomedical Engineering Award, the Huaxia Medical Science and Technology Award, the Chinese Medical Science and Technology Award, the China Patent Excellence Award, as well as various Science and Technology/Invention Awards from multiple provinces and cities."

BCIFlex Medical's Dual Certification Achieved, Mass Spectrometry Innovation Strength Recognized by International Authorities

Recently, BCIFlex Medical successfully passed the SGS ISO 9001 Quality Management System certification, and its two core mass spectrometry testing platforms passed the CE standard tests! SGS is an internationally recognized inspection, verification, testing, and certification body. ISO 9001, as the globally acknowledged benchmark for quality management systems, was developed by the International Organization for Standardization (ISO). Its core requirement is to establish a systematic process mechanism to ensure that products and services consistently meet customer needs and regulatory standards, achieving continuous improvement through the PDCA cycle (Plan-Do-Check-Act). At the same time, the two core mass spectrometry testing platforms, LC-MS/MS and ICP-MS, successfully passed the rigorous tests conducted by SGS, the international authority, in environmental protection, electrical safety, and EMC, fully complying with EU mandatory requirements, and officially obtained the "passport" to enter the market of the 31 member states of the European Economic Area (EEA). The implementation of these two internationally authoritative certifications not only represents a dual affirmation of BCIFlex Medical's quality management and product compliance but also marks a milestone step in the company’s global expansion.

YouSiDa's First China-Produced MTC/NTM Molecular POCT Differentiation Test Kit Approved for Marketing

Recently, the Mycobacterium (MTC/NTM) Nucleic Acid Detection Kit developed by YouThink Bio has passed the NMPA Class III medical device approval, becoming the first molecular POCT product in China capable of accurately differentiating between MTC and NTM. Molecular diagnostics, known for high sensitivity and compatibility with diverse sample types, is recommended as the preferred method in guidelines and expert consensus. The YouThink EasyNAT MTC/NTM is the first molecular POCT differentiation reagent, filling a market gap. Its fully enclosed integrated test tube requires only a single sample addition, automating the entire process of sample lysis, magnetic bead extraction and purification, nucleic acid amplification, and fluorescence analysis, delivering results within one hour. One tube enables simultaneous detection and precise differentiation of MTC and NTM, providing clear guidance for clinical decision-making.

BiHeart's IBERIS RDN System Officially Receives Market Access Qualification in Spain

On August 19, 2025, Shanghai Antong Medical Technology Co., Ltd. ("Antong Medical" for short) achieved significant progress in overseas markets: its self-developed Platinium Iberis Renal Denervation System (Iberis RDN System) has successfully completed the commercial registration and filing process in Spain. Officially confirmed by the Spanish Agency of Medicines and Medical Devices (AEMPS), the system has been formally included in Spain's National Medical Device Database, allowing it to be commercially sold and clinically applied in Spain. The market approval of the Platinium Iberis RDN System in Spain holds substantial importance both clinically and for corporate development: from the perspective of medical practice in Spain, the introduction of this system provides local clinicians with an innovative interventional treatment option for hypertension, particularly offering new therapeutic choices and hope for patients with poorly controlled blood pressure or those intolerant to multiple medications. For Antong Medical, this regulatory approval in Spain represents a key milestone in the company’s internationalization strategy, signifying that its interventional hypertension technology has gained recognition in the global market for clinical transformation and cross-border application. Currently, the system has completed commercial deployment in Germany, Spain, and Italy, with the Irish market currently under way. Notably, Germany and France have already incorporated the system into their medical insurance coverage. These developments lay a solid foundation for the global promotion of subsequent products and accelerate the deepening of Antong Medical’s globalization strategy.

Haiskell Partners with Innovent Bio for Comprehensive Strategic Cooperation, Using Non-Invasive Diagnostic Innovations to Jointly Build a Scientific Weight Loss Ecosystem

On August 10, 2025, during the deepening advancement of the national "Weight Management Year" special campaign, the "Shaping Health - 2025 Weight Management Industry Conference," guided by the National Biomedicine Innovation Center and hosted by Innovent Bio, was successfully held in Suzhou. During this industry conference, HiskyTech and Innovent Bio completed the signing of a strategic cooperation agreement. The implementation of this agreement also marks that the two parties will join hands to target the core health threat facing 500 million overweight and obese adults in China—fatty liver disease—and initiate precise diagnosis and scientific intervention in weight management, supporting Healthy China. The strategic collaboration between HiskyTech and Innovent Bio signifies a profound shift in scientific weight loss from "simple weight reduction" to "precise intervention in visceral health risks." The iLivTouch® non-invasive liver detection technology, as the core "eye" for understanding metabolic health, will provide indispensable scientific evidence for weight management.

BioMap and Jinxin Technology Reach Strategic Cooperation to Create a Global Benchmark for AI in Assisted Reproduction

Recently, BioMap, the global pioneer in foundational life science large models, and Jinxin Technology, the leader in China’s assisted reproductive services, officially announced a strategic partnership. Leveraging their respective strengths and complementary resources, the two parties will jointly develop an AI-powered intelligent system for assisted reproduction — the world's leading assisted reproductive intelligence platform. Through advanced AI technology, they aim to enhance efficiency standardization in reproductive processes, enable data-driven decision-making in the industry, optimize cycle trend predictions, and upgrade medical team training systems. Together, they will explore cutting-edge fields with the ultimate goal of optimizing IVF-assisted reproductive procedures and improving service experiences. The significance of this collaboration goes beyond the mere integration of technologies within a single domain; it introduces a new driving force of "AI + bio-intelligent evolution" into the assisted reproductive industry. Moving forward, the two parties will explore personalized AI-driven solutions, build dynamic treatment models, and provide comprehensive data support throughout the entire process, from ovulation induction dosage records to embryo transfer. They will also create a dedicated AI assistant for maternal and child health, offering full-cycle parenting knowledge services, developmental warning systems, and emotionally interactive features. Additionally, they will pioneer a new paradigm in assisted reproductive research by breaking data silos, constructing cross-modal reproductive large models, and exploring mechanisms of reproductive aging to identify potential research directions for ovarian function preservation. As the AI-assisted reproductive intelligence cluster is implemented across multiple pilot hospitals under Jinxin, a reproductive medicine revolution — shifting from experience-driven to data-intelligent practices — will be set in motion.

Haihe Biotech and Avivid Biotech Build an Innovative Ecosystem for Organ-on-a-Chip, Driving Transformation in the Biopharmaceutical Industry

Recently, Tianjin Haihe Biomedical Technology Group Co., Ltd. ("Haihe Bio") and Jiangsu Aiweide Biotechnology Co., Ltd. ("Aiweide Bio") signed a strategic cooperation agreement. The two parties will leverage their respective core strengths to build a comprehensive service platform for biomedical foundational research and industrial transformation centered on organ-on-a-chip technology. They will establish an organ-on-a-chip central laboratory to inject new momentum into areas such as compound screening, drug safety and efficacy evaluation, and precision oncology. Together, they aim to drive a significant leap in China’s organ-on-a-chip industry from general basic scientific research services to empowering pharmaceutical innovation and R&D. This collaboration marks a higher level of synergy between Haihe Bio and Aiweide Bio in "organ-on-a-chip-pharmaceutical research." The full lifecycle service system for drug R&D of Haihe Bio will be highly integrated with the organ-on-a-chip technology of Aiweide Bio, establishing a new paradigm for pharmaceutical innovation and significantly improving R&D quality and clinical translation effectiveness.

LCP's Multiple Healthcare Portfolio Companies Ranked on 'Top 101 China Pharmaceutical Industry 2025' and Ten Core Industrial Chain Lists

On August 2, the 7th China Pharmaceutical Industry Expo (CMC-CHINA 2025) successfully concluded at the Suzhou International Expo Center. During the exhibition, the much-anticipated "Top 101 of China's Pharmaceutical Industry 2025" and the top ten core industry chain rankings were released, with several medical companies invested in by Legend Capital earning a place on the list.

Top 30 API Businesses in China 2025

WuXi AppTec

Pharmaron

Top 25 Small Molecule CDMOs in China 2025

WuXi AppTec

Pharmaron

Liuhe Ningyuan

Dooch Pharm

Top 20 Large Molecule CDMOs in China 2025

WuXi Biologics

Prosper Bio

BCIFlex

Pharmaron

Top 20 Clinical CROs in China 2025

ClinChoice

WuXi AppTec

Novotech

Xihua Testing

Top 20 Preclinical CROs in China 2025

WuXi AppTec

Pharmaron

SaiFu Pharmaceuticals

Top 101 Innovative Pharmaceutical Companies in China 2025

Innovent Bio

Harbour BioMed

RiboBio

PegBio

Yilian Bio

Anjiste Bio

Lynk Pharmaceuticals

Innovent Bio Awarded "2025 China's Hidden Unicorn 500"

On August 23, the 2025 China Hidden Unicorn 500 Strong Conference, jointly organized by the China Invention Association, the Chinese Council of the BRICS Business Council, and the Beijing Hidden Unicorn Information Technology Institute, was grandly held in Guangzhou. Shenzhen Signa Biotechnology Co., Ltd. (hereinafter referred to as "Signa Biotech") successfully made it onto the "2025 China Hidden Unicorn 500 Strong" list and was awarded a certificate due to its continuous innovation and technological breakthroughs in the field of mRNA innovative therapies and LNP delivery technology. As a leading innovator in the global mRNA sector, Signa Biotech has always focused on the research and development of its proprietary LNP (lipid nanoparticle) delivery technology platform and is actively promoting breakthrough applications of this technology in various fields such as infectious disease vaccines, chronic diseases, autoimmune diseases, rare diseases, and oncology. The company is committed to providing innovative solutions for unmet clinical needs, making cutting-edge technology accessible to a broader patient population. Relying on its core LNP delivery technology platform, Signa Biotech demonstrates strong R&D capabilities and highly efficient industrialization potential. The company has established a rich R&D pipeline and formed strategic partnerships with multiple international enterprises and institutions, showcasing broad market prospects and development opportunities. Being named one of the "China Hidden Unicorn 500 Strong" fully reflects the industry and investment community's high recognition of Signa Biotech’s achievements in technological innovation, business models, and growth speed.

BoYin Hearing Selected for Shanghai's 2025 "Specialized, Refined, Unique, and Innovative" SME List

Recently, the Shanghai Municipal Commission of Economy and Informatization announced the list of specialized, refined, distinctive, and innovative small and medium-sized enterprises for 2025 (second batch). Boyin Hearing Technology (Shanghai) Co., Ltd. successfully made it to the list due to its technological innovation and outstanding performance in the field of hearing health. This is a high recognition of Boyin Hearing's commitment to independent innovation and dedication to the hearing health industry. Since its establishment in 2019, Boyin Hearing Technology (Shanghai) Co., Ltd. has been focusing on the research and development of intelligent hearing aid technology and the production of medical-grade hearing aids. It is a national high-tech enterprise integrating design, R&D, production, and sales. The company adopts an innovative model of "AI Intelligent Hearing Aids + Hearing Expert Center" and, relying on its self-developed "Cloud Listening" series of hearing aid chips, has successfully broken through the highly integrated technology of hearing aids and Bluetooth chips, achieving independent control over core technologies.

Core Medical Wins Three Major Industry Awards, China's Medical Device Innovation Strength Recognized Again

Recently, Shenzhen Core Medical Technology Co., Ltd. (hereinafter referred to as "Core Medical") has gained recognition from multiple platforms. In May, it won the "2025 VBEF Future Healthcare 100 Strong – China's Innovative Medical Devices and Intelligent Manufacturing TOP100." In June, it was honored with the "2025 Sci-Tech Golden Bull Award (Biopharmaceuticals)," and in July, it received the "Annual Innovative Medical Device Best Enterprise" award. These accolades not only reaffirm Core Medical’s groundbreaking technological breakthroughs and significant contributions in the ventricular assist device (VAD) field but also highlight deep recognition of its commercial performance, international progress, and comprehensive product matrix for heart failure management across the entire life cycle. The three honors not only acknowledge Core Medical’s past technological achievements, commercial successes, and strong future growth potential but also bolster its global strategic layout with sustained momentum. With Corheart® 6, DuoCor®, and CorVad® as its core products, Core Medical fully covers both implantable and interventional artificial heart devices. Moving forward, the company will continue to leverage its foundational innovation strengths, focusing on profound advancements in the VAD sector: accelerating the iteration and diversification of core technologies and R&D; expanding applications in full-life-cycle heart failure management and critical care circulatory support; while simultaneously speeding up international expansion. Through industrial acceleration, Core Medical aims to help China achieve high-level self-reliance in advanced medical equipment, ultimately building a more reliable lifeline for over 60 million heart failure patients worldwide.

Nona Biosciences Shortlisted for 2025 Galien Award "Best Startup," Innovative Technology Platform Receives International Recognition

Known as the "Nobel Prize of the pharmaceutical industry," the Galien Award (Prix Galien USA Awards) recently announced its 2025 list of nominees. Nanor Bio has successfully made it to the shortlist for the "Best Startup" award, thanks to its industry-leading HCAb Harbour Mice® antibody technology platform and innovative R&D achievements. The Galien Award is one of the most prestigious awards in the global biopharmaceutical field, established by The Galien Foundation, with strict evaluation criteria considering scientific innovation, technical breakthroughs, and industry influence. Nanor Bio’s inclusion on the nominee list fully demonstrates that its outstanding innovation potential and technological leadership in the field of antibody drug development have gained international authoritative recognition. Nanor Bio's proprietary Harbour Mice® antibody technology platform is a globally rare fully human antibody R&D platform capable of generating fully human monoclonal antibodies in dual, double light chain (H2L2), and heavy-chain only (HCAb) formats. HCAb molecules are about half the size of conventional antibodies, maintaining strong antigen recognition capabilities while offering better tissue penetration. Moreover, due to the absence of light chain mispairing issues, HCAb holds inherent advantages in emerging drug fields such as bispecific/multispecific antibodies, ADCs, CAR-T, and mRNA, serving as the "underlying framework" for complex molecular constructs. The HCAb PLUSTM platform, developed based on HCAb, encompasses four cutting-edge core technologies spanning protein engineering, antibody conjugation, drug delivery systems, and cell therapy, showcasing broad application prospects in today’s “Antibody+ (Ab+)” era.