MaiJing Gene Secures Hundreds of Millions in Series C Funding and Receives NMPA Approval for Lung Cancer PCR Multi-Gene Companion Diagnostic Kit

VCBeat has learned at the earliest opportunity that,Guangzhou Maijing Gene Medicine Science and Technology Co., Ltd.(hereinafter referred to as“Maijing Gene”）Completion AnnouncedHundreds of millions of yuanSeries CFinancing. This round of financing was led byEfung CapitalLead Investor,Anggu Fuge, Jiuyou Capital, Bench Capital, Hongtu RundaCo-investment. The funds raised will be used for R&D investment andIVD Product Registration.

During the same period, Maijing Gene's self-developed productsLung Cancer PCR Multi-Gene Companion Diagnostic Kit (Trade Name: Maifeijie)It has also received marketing approval from the National Medical Products Administration (NMPA) (NMPA Registration No. 20223401432), becomingThe first non-small cell lung cancer PCR multi-gene detection kit with companion diagnostic functionality approved by the NMPA in China.

Founded in 2015 and headquartered on Guangzhou International Bio Island, Maijing Gene has established branch offices in East, Central, and North China. Adhering to a customer-centric service philosophy since its inception, the company is dedicated to providing comprehensive solutions in the field of precision oncology. To date, it has evolved into a high-tech enterprise integrating research and development, manufacturing, sales, and services.

The company leverages both PCR and NGS technology platforms to develop a series of molecular diagnostic products for tumor diagnosis, classification, monitoring, and screening, covering the entire continuum of cancer care and serving hundreds of Grade A tertiary hospitals across China. Maijing Gene remains committed to leveraging its technological advantages to focus on the research and development of molecular testing products tailored to the needs of Chinese patients, physicians, and medical institutions.

Maijing Gene's Lung Cancer"Maifeijie" PCR Multi-Gene Companion Diagnostic Kit

The newly approved product “Maifeijie” covers the core genes required by lung cancer diagnosis and treatment guidelines, enabling the detection ofEGFR、ALK、ROS1multiple core driver genes in non-small cell lung cancer (NSCLC), and has undergone comprehensive clinical validation of its companion diagnostic utility for targeted therapies. The product also offers advantages such as ease of operation, straightforward implementation, and rapid turnaround time for reporting, effectively addressing the clinical need in China for both comprehensive and rapid testing in the first-line treatment of patients with advanced NSCLC.

In the field of oncology companion diagnostics, although PCR technology has been applied for many years and numerous certified products are available, the high investment and technological barriers, coupled with a lengthy and rigorous approval process, have resulted in a scarcity of multi-analyte testing products on the market.

According to Li Mengzhen, co-founder of Maijing Gene, the company has its own understanding and judgment of China’s molecular diagnostic market for oncology and will conduct product development and marketing based on its own strategic logic. One year after its establishment, the company initiated the project for a PCR-based multi-gene companion diagnostic kit for lung cancer and began regulatory registration preparations in 2018. Despite numerous challenges, Maijing Gene steadfastly advanced in accordance with its strategic plan. The entire application process spanned nearly four years, involving seven centers across China—all large tertiary Grade A hospitals and specialized oncology hospitals—with nearly 2,000 samples enrolled, ultimately leading to the approval and market launch of “Maifeijie.”

With the increasing regulatory compliance in the genetic testing industry, the implementation of related genetic tests within hospitals has become a key development direction. Maijing Gene’s lung cancer PCR-based multi-gene companion diagnostic kit, “Maifeijie,” is poised to play a significant role, serving as a powerful tool to facilitate convenient and compliant in-house tumor genetic testing for hospitals. Maijing Gene’s NGS and PCR kits for other cancer types are also currently undergoing registration applications and clinical trials.

Meeting the clinical needs of Chinese cancer patients and complying with domestic regulatory requirements are the foundational prerequisites for Maijing Gene’s product portfolio strategy.

Since its establishment in 2015, Maijing Gene has grown from humble beginnings into a robust enterprise. Driven by an innovative research spirit and leveraging cutting-edge industry technologies, the company adheres to a customer-centric service philosophy. It strives to provide cancer patients with the most up-to-date and professional guidance for personalized precision treatment, positioning itself as a comprehensive provider of precision oncology solutions.

Regarding this round of financing,Yang Dongcheng, Founder of Maijing Gene“We extend our gratitude to investors for their recognition and support of Maijing Gene. As national healthcare reform policies continue to deepen, the Chinese government has provided strong support for domestically produced medical devices and reagents, while the capital market has paid particular attention to the development of the in vitro diagnostics (IVD) industry. Maijing Gene has long been committed to tumor molecular diagnostics, focusing on R&D across multiple technology platforms and product registrations. After years of refinement by our team, our flagship product, Maifeijie, has finally received approval for market launch. Staying true to our original mission, we press forward with renewed determination. Moving forward, we will continue to innovate, serving Chinese patients with more advanced technologies and more reliable testing products.”

Zhu Pai, Managing Partner of Efung CapitalIt stated: “Congratulations to Maijing Gene for obtaining NMPA approval for the market launch of its lung cancer PCR-based multi-gene companion diagnostic kit (trade name: Maifeijie). The molecular diagnostics industry is in a period of rapid growth, particularly in the companion diagnostics segment. PCR will remain the mainstream technology for companion diagnostics in the short to medium term; while the market for single-gene testing is shrinking, the multi-gene testing market is experiencing rapid growth with insufficient competition. NGS represents the long-term development trend and shows overall growth; however, regulatory approvals for large panels face obstacles and their clinical significance remains to be validated, whereas small panels are more aligned with actual clinical needs. Maijing Gene has long been dedicated to its dual-technology platform of PCR and NGS, striving to create comprehensive solutions for tumor molecular diagnostics that truly meet customers’ diverse needs. Notably, it has achieved full marks in the National Center for Clinical Laboratories (NCCL) external quality assessment for high-throughput sequencing detection of somatic mutations in solid tumors for five consecutive years. We look forward to Maijing Gene’s orderly advancement of its subsequent pipeline, providing high-quality companion diagnostic products to more patients.”

Zhou Yang, Partner at Angu Fuge“It took Maijing Gene seven years of dedicated effort to hone its craft. Amidst a complex and volatile industry landscape and increasingly fierce market competition, the company has remained true to its original mission, overcome significant challenges, and developed core products with distinct differentiated competitiveness. This achievement has also facilitated Maijing’s successful transformation from a traditional genetic testing service provider into an innovative sequencing technology product company. With a commitment to steady progress and long-term perseverance, we believe that Maijing will leverage its mature product offerings and tiered pipeline of reserve projects to build on its inherent strengths, precisely align with market demands, and achieve even greater success.”

Sun Yi, Managing Partner at Jiuyou Capitalstated: “The Maijing Gene team combines expertise in diagnostic R&D with sales and management capabilities, boasting extensive experience and a broad vision in the field of medical diagnostic services. We are also pleased to note that, thanks to its foresight into industry trends and efficient execution, coupled with the collective efforts of its team, Maijing has secured the first domestic approval for a PCR-based multi-gene companion diagnostic kit for lung cancer. We hope that Maijing will better serve patients in the future and realize greater clinical value in precision oncology.”

Managing Partner at Bench Capital, Ping Jiestated: “First and foremost, we extend our warmest congratulations to the company for the recent successful approval and market launch of its ‘PCR-based Multi-gene Companion Diagnostic Kit for Lung Cancer.’ After seven years of dedicated effort, it has become the first PCR-based multi-gene companion diagnostic kit for lung cancer approved in China. Achieving such remarkable progress amidst a highly complex and volatile internal and external environment is no small feat. We recognize ‘Maijing Gene’ as an ‘Outstanding Performer’ across five key dimensions: a promising sector, superior technology, a strong team, supportive shareholders, and solid business performance. We are honored to have become one of the company’s shareholders during the early stages leading up to this breakthrough. We believe that, with a higher market positioning and more ambitious goals, the company will continue to deliver innovative products that meet clinical needs, serve a broad patient population, and create greater value.”

A specialized pharmaceutical investment institution, Efung Capital’s investment team comprises PhDs in biomedicine from top-tier universities both in China and abroad. Focusing on global venture capital (VC) and private equity (PE) investments in the biopharmaceutical sector, the firm has made deep investments in more than 80 high-quality domestic and overseas enterprises, including Chipscreen Biosciences, Frontier Biotechnologies, Ascentage Pharma, Pumen Technology, Yihong Pharmaceuticals, Obio Technology, Real Therapeutics, Kesheng Biotechnology, Huahao Zhongtian, 3D Medicines, and Yinming Biologics. Leveraging its outstanding investment performance and research capabilities, Efung Capital has been honored as one of the Top 30 Healthcare Investment Institutions in China by Zero2IPO, recognized among the Top 10 Best Exit Cases in the Biopharmaceutical Sector, and acclaimed as China’s Most Dynamic Innovative Drug Investment Institution. The firm was also featured in an exclusive interview by Nature, the world-renowned scientific journal.

Efung Capital is dedicated to advancing the industrialization of biotechnological achievements through capital investment, striving for the progress of life sciences. Over years of accumulation, Efung Capital has established a philosophy centered on entrepreneurs and grounded in value creators. It has built a professional investment team with extensive experience and distinct characteristics, and adheres to a systematic “five-in-one” operational model integrating investment, financing, risk control, management, and services. The firm is committed to becoming an outstanding investment institution that is people-oriented, trustworthy, and built for enduring success.

Jiuyou Capital was founded in 2015 by an elite team with extensive investment experience in the industry. With a global perspective, the firm remains committed to focusing on life sciences and innovative technologies as its core investment sectors. Leveraging its abundant platform resources, professional due diligence capabilities, and comprehensive post-investment services, Jiuyou Capital supports equity investments across multiple stages, from angel rounds to Pre-IPO rounds. Its portfolio companies, including Tianyi Shangjia (688033), Cambricon Technologies (688256), and Tianqin Equipment (300922), have successfully gone public.

Jiuyou Capital has been honored with awards including 36Kr’s “Top 20 Investment Institutions in China’s Healthcare and Wellness Sector 2021,” 36Kr’s “Top 100 Venture Capital Firms Most Welcomed by Entrepreneurs in China 2021,” CVSource’s “Top 100 Best Venture Capital Firms in China 2020,” and the Zhuoyue Rankings’ “Best Investment Institution in Biopharmaceuticals 2020.”

Bench Capital is a boutique investment firm dedicated to investing in potential top-tier tech unicorns, adhering to a strategy of selective and high-quality investments. Established in May 2015, the company leverages profound industry insights and an elite network of resources to focus on high-tech sectors such as next-generation information technology, advanced manufacturing, and biotechnology. Prioritizing companies in their rapid growth stage, Bench Capital has successfully invested in numerous star projects to date, including unicorn enterprises such as Qi-An-Xin, TSL (Teslian), and LandSpace. Guided by the principle of "seeking progress while maintaining stability," its investment philosophy is to "generate excess returns under relatively safe conditions." Furthermore, Bench Capital employs a dual-wheel drive model of "investment + empowerment," integrating resources from local governments and upstream and downstream industry partners to empower portfolio companies, ultimately achieving a win-win outcome for all stakeholders.