Junlian Medical Enterprise Development Update · Issue 2, 2025

Feb 28, 2025 17:31 CST Updated 17:31

Innovent

High-end Biologics Developer

Nuwacell

Cell Therapy Product Developer

Ribo Life Science

Small Nucleic Acid Drug Developer

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Innovent Bio Announces the First China-DevelopedCTLA-4 Monoclonal Antibody Ipilimumab InjectionNew Drug Application for Neoadjuvant Treatment of Colon Cancer with Sintilimab Accepted and Granted Priority Review

February 24, 2025, San Francisco, USA, and Suzhou, China — Innovent Bio (Stock Code: 01801.HK), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, announced that the New Drug Application (NDA) for Ipilimumab Injection (CTLA-4 antibody, R&D code: IBI310) in combination with Sintilimab for neoadjuvant treatment of resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted priority review. This NDA acceptance and priority review designation is based on the results of a randomized, controlled, multicenter, Phase III registrational study (NeoShot, NCT05890742) conducted in China. The study aims to evaluate the efficacy and safety of Ipilimumab in combination with Sintilimab as neoadjuvant therapy for resectable MSI-H/dMMR colon cancer compared to upfront radical surgery. The primary endpoints of the study are pathological complete response rate (pCR) and event-free survival (EFS). An interim analysis of the NeoShot study showed that the pre-specified primary endpoint was met, as assessed by the Independent Data Monitoring Committee (iDMC), and the relevant findings are planned for publication at upcoming academic conferences or in academic journals.

Anhui Zhongsheng Traceability Biotechnology Co., Ltd.'s Gene-Modified iMSC Approved for Clinical Use Globally for the First Time

On February 19, 2025, the CDE official website announced that the "NCR101 Injection" submitted by Zhongsheng Traceability (Guangzhou) Biotechnology Co., Ltd. has been granted clinical tacit permission for the treatment of interstitial lung disease (ILD). NCR101 is the world's first induced pluripotent stem cell (iPSC)-derived genetically modified mesenchymal-like cell (MSC) therapy product to be approved for clinical trials. It is also the second iPSC-derived MSC (iMSC) product from Zhongsheng Traceability to receive clinical approval, following the "NCR100 Injection." Zhongsheng Traceability focuses on developing widely accessible iPSC-derived cellular therapy products. In the future, it will continue to advance the research and development of various cell drug pipelines in the three major fields of anti-inflammatory repair, tumor immunity, and regenerative medicine. Currently, the "NCR100 Injection" (iPSC-derived mesenchymal-like cells, iMSC) for the treatment of knee osteoarthritis has progressed to Phase 2 clinical trials; the "NCR300 Injection" (iPSC-derived natural killer cells, iNK) for the treatment of myelodysplastic syndromes and the prevention of AML recurrence after allo-HSCT is in Phase 1/2 clinical trials. Subsequently, other iPSC-derived cell therapies targeting additional indications will also enter the registered clinical trial stage.

Ribo Life Science's siRNA Drug RBD2080 for Treating Autoimmune Diseases Approved for Clinical Trials in Australia

Suzhou Ribo Life Science Co., Ltd. recently announced that its self-developed siRNA drug RBD2080 for the treatment of autoimmune diseases has received approval from the Australian Therapeutic Goods Administration (TGA) and will soon commence Phase I clinical trials in Australia. This clinical trial is a randomized, double-blind, placebo-controlled Phase I study aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RBD2080 in healthy subjects with single and multiple ascending doses. RBD2080 is the sixth innovative small nucleic acid drug developed by the company based on its RIBO-GalSTARTM liver-targeting technology platform, precisely targeting specific genes associated with autoimmune diseases to effectively regulate gene expression, thereby fundamentally intervening in disease progression. Compared with traditional treatments, RBD2080 offers advantages such as precise targeting and long-lasting efficacy, providing the potential for a superior treatment option for patients.

Harbour BioMed's HBM9378/SKB378 Clinical Trial Application for Chronic Obstructive Pulmonary Disease Approved

Harbour BioMed (Stock Code: 02142.HK), a global biopharmaceutical company focused on the discovery, development, and commercialization of innovative antibody therapies in the fields of oncology and immunology, recently announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its fully human antibody HBM9378/SKB378 (now also known as WIN378), which targets Thymic Stromal Lymphopoietin (TSLP), for the treatment of Chronic Obstructive Pulmonary Disease (COPD). HBM9378/SKB378 (now also known as WIN378) is an antibody drug co-developed by Harbour BioMed and Kelun-Biotech, with both parties jointly owning the rights in Greater China and certain Southeast Asian and West Asian countries. Currently, Harbour BioMed has completed the Phase I clinical trial of HBM9378/SKB378 in China for the treatment of moderate to severe asthma, and a Phase II clinical trial for this indication is about to commence.

Corsaire Bio's Class 1 Anticancer New Drug Sepantronium Bromide Injection Approved for Clinical Trials Again

On February 18, 2025, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) announced that Cothera Bioscience's investigational new drug, Sepantronium Bromide Injection, had been approved again for clinical trials to treat neuroendocrine prostate cancer. Previously, this product had already received clinical approval in China for the development to treat relapsed/refractory c-Myc-driven Burkitt Lymphoma or other high-grade B-cell lymphomas. Sepantronium Bromide (code name: PC-002) is one of Cothera Bioscience's core products and is a deubiquitinating enzyme (DUB) inhibitor. Its mechanism of action not only induces MYC protein degradation but also inhibits the anti-apoptotic protein survivin at certain concentrations, thereby achieving a dual effect on MYC-driven tumors. Currently, Cothera Bioscience is developing PC-002 for multiple tumor diseases, including neuroendocrine prostate cancer, Burkitt Lymphoma, and other MYC-driven cancer types. Cothera presented the latest clinical results from the PC002-01 clinical trial at the 2024 American Society of Hematology Annual Meeting.

Deeply Believing Biology's Fourth Rare Disease mRNA Drug IN013 Granted FDA Pediatric Rare Disease Designation

On February 21, 2025, Innorna, a clinical-stage biopharmaceutical company focusing on lipid nanoparticle (LNP) delivery technology and the development of innovative RNA therapies, announced that its self-developed fourth rare disease mRNA drug, IN013, has been granted Rare Pediatric Disease Designation (RPDD) by the U.S. FDA. IN013 is used to treat Wilson's disease, a life-threatening genetic disorder of copper metabolism. The granting of this RPDD represents the FDA’s dual recognition of the clinical value of IN013 and Innorna’s R&D capabilities, further confirming the leadership of Innorna’s mRNA-LNP technology platform.

MediLink Bio YL217 Project Receives FDA Clinical Trial Approval

On February 2, 2025, Medilink Therapeutics (Suzhou) Co., Ltd., a clinical-stage biotechnology company, announced that its self-developed antibody-drug conjugate (ADC) YL217 received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). YL217 is the 11th ADC drug developed based on Medilink Therapeutics' proprietary TMALIN® technology platform to enter clinical trials. YL217 is an antibody-drug conjugate targeting an innovative antigen, primarily developed for gastrointestinal tumors. The target of YL217 is highly expressed in tumor tissues such as gastric cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma, with its expression associated with metastatic progression in various cancers of gastrointestinal origin and upregulated in advanced, well-differentiated tumors. Developed using Medilink Therapeutics' next-generation tumor microenvironment-activatable linker-payload platform technology (TMALIN®), YL217 will soon initiate Phase I clinical trials.

ReCO Bio's New Adjuvant Recombinant Nine-valent HPV Vaccine Clinical Trial Application in China Accepted

On February 12, 2025, Recbio (02179.HK) is pleased to announce that it has received the acceptance notice issued by the National Medical Products Administration, approving the clinical trial application for its self-developed new adjuvant recombinant nine-valent HPV vaccine REC604c. REC604c is a new type of recombinant nine-valent HPV vaccine that the company plans to develop for the male market and the premium market. This product is an upgrade of the previous generation of nine-valent HPV vaccines, equipped with the company's proprietary new adjuvant, aiming to reduce the number of vaccinations by enhancing immunogenicity and cross-protection, effectively improving the accessibility of the product. Preclinical studies have shown that, at the same immunization dose, two doses of REC604c induced overall superior immunogenicity compared to three doses of Merck's Gardasil®9.

RapidGen Therapeutics' ART002 Achieves Therapeutic Saturation in Humans and Safely and Effectively Lowers LDL-C

On February 18, 2025, data from the investigator-initiated trial (IIT) titled "A Multicenter, Open-label, Single-arm, Exploratory Clinical Study of ART002 Injection for the Treatment of Heterozygous Familial Hypercholesterolemia," initiated by PrecisionGen Biotherapeutics (Suzhou) Co., Ltd. and the First Affiliated Hospital of Bengbu Medical College, showed that a single administration of ART002, an in vivo gene-editing product independently developed by PrecisionGen Biotherapeutics, could achieve therapeutic saturation and safely and effectively reduce low-density lipoprotein cholesterol (LDL-C). Following the failure of a similar product by U.S.-based Verve Therapeutics in earlier clinical trials, ART002 has become the world's first in vivo gene-editing product to achieve this goal in humans, marking a critical step forward in the treatment of hypercholesterolemia through in vivo gene editing. ART002, independently developed by PrecisionGen Biotherapeutics, is a novel in vivo gene-editing drug delivered via LNP, designed to precisely edit the LDL-C regulatory gene PCSK9 with a single administration to achieve long-term reduction of LDL-C levels and lower the risk of cardiovascular disease. The IIT clinical study of ART002 was launched in mid-2024, and among the enrolled subjects, two-thirds had baseline LDL-C levels exceeding 6.2 mM (24 mg/dL).）, much higher than the baseline levels of clinical trial participants for the siRNA drug inclisiran (3.3-3.7 mM) and PCSK9 antibody participants (mostly 3-5 mM), indicating that ART002 participants face greater treatment challenges compared to existing products.

Biheart Iberis® Multi-Electrode RDN System Approved for Marketing

On February 26, 2025, the National Medical Products Administration released the "Information on the Delivery of Medical Device Approval Documents on February 26, 2025." The Iberis® Multi-Electrode Renal Denervation System, developed by Antong Medical under the Baxiang An Group, was approved for marketing. It became the third domestically produced renal denervation (RDN) product to be approved in China and the world's only RDN system compatible with both radial and femoral artery access that has received CE certification. The Iberis® Multi-Polar Renal Artery Radiofrequency Ablation Catheter System employs advanced renal nerve ablation technology. Through minimally invasive intervention, the ablation catheter is precisely delivered to the renal artery, using radiofrequency energy to fully ablate the renal sympathetic nerves and block the transmission of overactive renal sympathetic nerve signals. Results from the Iberis-HTN study showed that, compared to the sham procedure group, the RDN group experienced a significant reduction of 9.4 mmHg (P<0.0001) in 24-hour ambulatory systolic blood pressure at the 6-month follow-up. Additionally, the RDN group also demonstrated reductions in secondary endpoints such as 24-hour ambulatory diastolic blood pressure and office blood pressure, with good safety outcomes and no serious device-related adverse events, confirming the efficacy and safety of the Iberis® radiofrequency ablation system in treating primary hypertension. Grand Pharmaceutical (00512.HK) will collaborate with Shanghai Antong Medical Technology Co., Ltd. for an extensive and comprehensive strategic partnership across China regarding the Iberis® Multi-Polar Renal Artery Radiofrequency Ablation Catheter System.

Dingkang DK Score™ Coronary Scoring Balloon Receives CE MDR Certification

Recently, Dingkang Medical Technology (Suzhou) Co., Ltd. announced good news: its self-developed DK Score™ Coronary Scoring Balloon Dilation Catheter has successfully obtained the EU CE MDR certification (CE: M.2025.MDR.1062). This overseas CE certification not only recognizes the technical strength of the DK Score™ Coronary Scoring Balloon but also marks an important milestone in Dingkang Medical's international strategy. The CE certification is a mandatory certification by the EU for medical devices entering its market for sale. Obtaining this certification means that the product complies with relevant EU regulations and harmonized standards, qualifying it for sale in the EU and other countries and regions that recognize this certification. Since its establishment in 2015, Dingkang Medical has consistently adhered to innovation-driven development and has become a leading domestic enterprise in the full range of interventional balloon innovations in China. It has developed more than ten types of balloons, including standard balloons, high-pressure balloons, scoring balloons, and drug-coated scoring balloons. Its product line covers the needs of almost all vascular intervention fields, including cardiovascular intervention, peripheral intervention, and neurointervention.

Spectrum Medical SONICO-CX Receives Regulatory Approval in Peru

Recently, the SONICO-CX Coronary Intravascular Shockwave Treatment System developed by Puchuang Medical Technology (Shanghai) Co., Ltd. has received registration approval from DIGEMID in Peru. This marks another significant breakthrough in the Latin American market following its approval by ARCSA in Ecuador. As a regional benchmark market for medical innovation in Latin America, Peru's approval will create a demonstration effect for neighboring countries, helping the company further expand in the Latin American market. The SONICO-CX Coronary Intravascular Shockwave Treatment System is a domestically produced, self-developed product that has been granted patent authorization in China. The system offers several advantages, including more pulses (120 times), a smaller crossing profile, and a more comprehensive range of specifications. It can more precisely match blood vessels, facilitating better balloon adherence to the vessel wall, resulting in improved lithotripsy effects. These innovative features make it more efficient and safer when treating coronary artery calcification.

YouSiDa Bio EasyNAT Mycoplasma Genitalium Nucleic Acid Detection Kit Officially Approved for Marketing

Recently, the EasyNAT Mycoplasma Genitalium Nucleic Acid Detection Kit (China Medical Device Registration No. 20253400377) developed by YouThink Biotech has been officially approved for marketing! This product will provide clinical practice with a rapid diagnostic tool that combines accuracy and timeliness, safeguarding reproductive health. The YouThink EasyNAT Mycoplasma Genitalium Nucleic Acid Rapid Detection Kit supports non-invasive urine sample testing and delivers precise results within 45 minutes, significantly improving diagnostic efficiency and providing clinicians with timely and reliable medication guidance. Hangzhou YouThink Biotech, established in 2005, has been focusing on the research, development, production, and sales of innovative point-of-care molecular diagnostics (POCT) technologies and products. The company has built a proprietary technology platform, filed dozens of international and domestic invention patents, continuously participated in national science and technology major projects for infectious disease prevention and control, and received dozens of significant awards, including the "Second Prize of National Science and Technology Progress Award" and the "First Prize of Zhejiang Provincial Science and Technology Progress Award."

Harbour BioMed Incubated Company HBM Alpha Therapeutics Signs Strategic Collaboration and Licensing Agreement to Advance Novel Endocrine Therapy Development

Harbour BioMed (Stock Code: 02142.HK) incubated innovative biotechnology company HBM Alpha Therapeutics Inc. ("HBMAT" for short) announced a strategic collaboration and licensing agreement with a business partner to jointly advance novel corticotropin-releasing hormone (CRH)-targeted therapies for multiple diseases. Under the agreement, the partner secures exclusive rights to develop and commercialize HAT001 (a potent and selective neutralizing antibody targeting CRH, internally referred to as HBM9013 by Harbour BioMed) in global markets outside Greater China (including mainland China, Taiwan, Hong Kong, and Macau). HBMAT will receive total payments of up to $395 million, including upfront fees, development, regulatory, and commercial milestone payments, as well as tiered royalties based on future net product sales. Additionally, HBMAT is entitled to receive warrants for a minority stake in the partner company. HAT001/HBM9013 treats various diseases, including congenital adrenal hyperplasia (CAH), by neutralizing CRH. HAT001/HBM9013 aims to significantly improve current treatment standards and enhance patient outcomes, demonstrating robust preclinical efficacy in downregulating CRH-mediated adrenocorticotropic hormone (ACTH) induction and progressing towards clinical development.

Baiyang Medicine Partners with Roche to Promote the Commercialization of Classic Cancer Targeted Drug Mabthera®

On February 13, 2025, Qingdao Baheal Pharmaceutic Co., Ltd. (301015.SZ), a pharmaceutical industrialization platform, announced that the company had signed a commercial cooperation agreement with Roche (Shanghai) Pharmaceuticals Ltd. According to the terms of the agreement, Baheal Pharma will obtain the exclusive marketing rights for MabThera® (English trade name: MabThera, generic name: Rituximab), a classic tumor-targeting drug from Roche, in mainland China. With this renewed partnership, the two parties will further promote the accessibility of classic cancer drugs in China, providing more treatment options with original research quality to a wide range of patients. As the world's first monoclonal antibody specifically targeting the CD20 antigen, MabThera® is also the world’s first anti-tumor monoclonal antibody, ushering in a new era of targeted cancer therapy. Over more than 20 years, MabThera® has accumulated extensive clinical experience worldwide, benefiting over 6.8 million patients. The drug is mainly used to treat diseases such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. Currently, the product portfolio operated by Baheal Pharma covers four major categories: OTC and health products, prescription drugs (OTX), critical care drugs like oncology treatments, and high-end medical devices. With the addition of MabThera®, a classic product, Baheal Pharma's oncology product line continues to expand, creating synergies among multiple oncology products, which is expected to boost the company’s performance growth.

LePure Bio and Tongjin Stem Cell Sign Strategic Cooperation Framework Agreement to Jointly Build an Innovative Ecosystem for the Stem Cell Industry

On February 15, 2025, Tongjin Stem Cell and LeKuo Biotech officially signed a strategic cooperation agreement, announcing comprehensive collaboration in the fields of CGT technology research and development, intelligent manufacturing, and industrial application. They are committed to breaking industry barriers and accelerating the large-scale implementation of cell therapy and regenerative medicine. This partnership will leverage LeKuo Biotech's complete solutions in cell culture and Tongjin Stem Cell’s profound expertise in stem cell technology and industrial applications, promoting breakthroughs in key technologies and expediting advanced process transformation. Through joint technical efforts, resource sharing, and co-building an industrial ecosystem, both parties will advance the standardization and intelligent upgrading of advanced processes, supporting the collaborative development of the CGT industry and providing the market with more efficient and accessible cell therapy solutions.

Nona Biologics Signs Licensing Agreement with the University of Alabama at Birmingham to Advance Research in B Cell Development

Nona Biologics, an international innovative biotechnology company dedicated to cutting-edge technology innovation and providing partners with comprehensive Idea to IND (I to ITM) services covering target validation and the discovery-to-preclinical development of next-generation biomacromolecular drugs, announced that it has signed a licensing agreement with the University of Alabama at Birmingham (UAB) to support the university's research efforts in B-cell development. Under the terms of the agreement, represented by Dr. James Kobie of UAB, a non-exclusive license has been granted to use Nona Biologics’ H2L2 Harbour Mice® platform for the development of fully human antibodies. This will strongly promote the university’s researchers in achieving scientific breakthroughs in the field of B-cell development.

BoYin Hearing Aids and China Audio Association—Sound and Music Technology Committee Strategic Cooperation Initiated, Driving AI Hearing Aid Innovation and Upgrade

On February 26, 2025, the Audio Technology Committee of the China Electronics Audio Association and Boyin Hearing signed a strategic cooperation framework agreement at the headquarters of Boyin Hearing in Shanghai, officially launching their in-depth collaboration. As a platform under the China Electronics Audio Association for industry exchange, knowledge dissemination, and sharing the latest research and industrialization achievements, the Audio Technology Committee has extensive university resources and experience in industry-academia-research cooperation in the field of audio and music technology. It will empower Boyin Hearing to achieve the transformation and optimization of professional technologies and market results in the AI-powered hearing aid sector, using intelligence to provide more precise and smarter hearing solutions for individuals with hearing loss. Boyin Hearing Technology (Shanghai) Co., Ltd., established in 2019, focuses on the "AI-powered hearing aids + hearing expert center" field and is a national high-tech enterprise integrating design, R&D, production, and sales. Boyin Hearing has built a comprehensive system covering AI hearing aid product development, hearing assessment, customer experience, and after-sales service. The company has deployed over 300 stores across 91 cities in 23 provinces of China, helping tens of thousands of people with hearing impairments regain clear auditory experiences. This strategic cooperation with the Audio Technology Committee of the China Electronics Audio Association will provide strong support and assurance for Boyin Hearing in product development, production capacity planning, market expansion, and talent cultivation.

Qingdao Baiyang Pharmaceutical Rated as "2024 Shandong Province Gazelle Enterprise"”`, Innovation Strength and Development Potential Recognized Again`

Recently, the Shandong Provincial Department of Industry and Information Technology officially announced the "List of Gazelle and Unicorn Enterprises of Shandong Province for 2024." Qingdao Baion Pharmaceutical Co., Ltd. ("Qingdao Baion Pharmaceutical" for short), a subsidiary of Shanghai Baion Pharmaceutical Co., Ltd., has been approved as a Gazelle Enterprise of Shandong Province for 2024 due to its outstanding innovation capabilities and significant advantages in the field of high-end formulation technology. "Gazelle enterprises" refer to high-tech enterprises characterized by fast growth, strong innovation capabilities, and great development potential. These enterprises occupy leading positions in niche markets and have the potential to break through "bottlenecks" to achieve leapfrog development. The selection process involves strict procedures including enterprise application, recommendation by competent authorities, expert review, third-party credit rating, due diligence investigation, joint final review, and public announcement. As Baion Pharmaceutical's high-end controlled-release formulation research and manufacturing platform, Qingdao Baion Pharmaceutical focuses on the R&D, production, and manufacturing of advanced formulation technologies such as osmotic pump, pellet coating, and matrix tablets. Its production base has passed the cGMP (current Good Manufacturing Practice) certification by the U.S. FDA multiple times with "zero defects," and several products are produced and sold simultaneously in both China and the United States.

N1 Life's Dr. Zang Xiaoyu Awarded "2024 Forbes China New Sharp Innovator Entrepreneur Award"”

Recently, Dr. Zang Xiaoyu, founder and CEO of N1 Life, was awarded the 2024 Forbes China Rising Innovator and Entrepreneur Award. Initiated by Forbes China, this award aims to identify and honor innovative enterprises and individuals with the most growth potential and investment value in China. Dr. Zang Xiaoyu, a distinguished young talent under China’s National Key Talent Program – Qiming Youth Talent, Suzhou Jinji Lake Entrepreneurship Leadership Talent, one of Fortune China's Most Influential Businesswomen in 2024, a Forbes China Rising Innovator and Entrepreneur, and the 2023 China Annual Outstanding Young Scientist in Technology Transfer. In 2019, Dr. Zang founded N1 Life, which is committed to applying cutting-edge drug delivery technologies to clinical drug and product development. The company’s technology platform spans small molecules, peptides, nucleic acid drugs, and other fields, advancing multiple innovative pipelines in dermatological and ophthalmic diseases.

Further Reading

Junlian Healthcare Enterprise Development Dynamics · Issue 1, 2025

Junlian Healthcare Enterprise Development Dynamics · 2024 Annual Review and Issue 12, 2024

Junlian Healthcare Enterprise Development Dynamics · Issue 11, 2024

Junlian Healthcare Enterprise Development Dynamics · Issue 10, 2024

Junlian Healthcare Enterprise Development Dynamics · Issue 9, 2024