Junlian Medical Portfolio Highlights: Aidite Lists on ChiNext, Langxin Bio Closes Series B+ Round, and Multiple Innovations Advance in Global Clinical Development

Industry-leading dental restoration materials

and oral digital equipment provider Aidite

Successfully listed on the Growth Enterprise Market

On June 26, Aidite (301580.SZ), a leading provider of dental restoration materials and digital dental equipment invested in by Legend Capital, was successfully listed on the ChiNext. Aidite issued 19,029,382 shares for the first time at an issue price of RMB 44.95 per share, with an expected total fundraising amount of RMB 855 million.

Aidite, established in 2007, is a leading provider of dental restoration materials and digital dental equipment, with business operations spanning over 120 countries and regions worldwide. The company has consistently focused on the independent research, production, and sales of internationally competitive zirconia ceramic blocks and other dental restoration materials. Relying on its deep understanding of the dental industry and strong customer base, Aidite designs and sells digital dental equipment, transforming traditional dentistry through technological innovation and digitalization to promote the digital transformation and intelligent development of the dental industry. Aidite is a national-level specialized and innovative "little giant" enterprise and a national high-tech enterprise. Since its inception, the company has adhered to the concept of innovation-driven development, striving to launch products that meet market demands and enhance product competitiveness through technological R&D, aiming for import substitution and international market expansion. Through long-term R&D in zirconia preparation technology, the company has developed a full range of products covering high, mid, and low-end markets. Based on its extensive experience in zirconia materials and understanding of digital dental production processes, Aidite has vigorously expanded its digital dental equipment business, promoting the shift toward digitalization and intelligence in the field of dental restoration. As of December 31, 2023, Aidite and its subsidiaries have obtained 93 patents, including 92 valid domestic patents and 1 international invention patent.

Innostellar Biotherapeutics Completes B+ Round Financing

Advance the R&D and Industrialization of Gene Therapy Drugs

On June 11, Innostellar Biotherapeutics, an innovative gene therapy company, announced the completion of its B+ round of financing. Founded in 2020, Innostellar Biotherapeutics is committed to the research, development, and manufacturing of innovative gene therapy drugs. Since its establishment, the company has built a GMP-compliant, scalable platform for AAV production, capable of developing high-yield, high-quality gene therapy products with controllable costs. This round of financing will further accelerate Innostellar Biotherapeutics' R&D and industrialization progress in the field of innovative gene therapy drugs. Currently, the company has advanced five candidate molecules into clinical trials, taking the lead in conducting gene therapy clinical studies in three blinding eye disease indications and obtaining three IND approvals. Among them, the first pipeline product, LX101, for treating RPE65 mutation-associated inherited retinal dystrophy (IRD), has entered Phase III clinical trials; the second pipeline product, LX102, for treating wet age-related macular degeneration, has entered Phase II clinical trials; and the third pipeline product, LX103, for treating X-linked retinoschisis, has completed IIT trials on six patients, demonstrating significant safety and efficacy. Innostellar Biotherapeutics has been dedicated to the gene therapy field for hereditary and chronic ocular diseases for many years, establishing a foundation for the development of multiple pipeline products and industrialization technologies. The company closely collaborates with clinical medical scientists from renowned hospitals both domestically and internationally, aiming to enhance innovation capabilities and develop gene therapy products more efficiently, promoting their clinical application to benefit patients.

Innovent Bio IBI343 Obtained

FDA Fast Track Designation

Treatment of Advanced Pancreatic Cancer

June 13, 2024, San Francisco, USA, and Suzhou, China — Innovent Bio (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune disorders, metabolic diseases, and ophthalmology, announced that its Claudin18.2 (CLDN18.2)-targeted antibody-exatecan conjugate (ADC) IBI343 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). The proposed indication is for patients with advanced pancreatic ductal adenocarcinoma who are CLDN18.2-positive and have received at least one prior systemic therapy. Previously, the FDA had already approved the Investigational New Drug (IND) application for IBI343 for the treatment of pancreatic cancer. The Fast Track Designation (FTD) is a process set up by the FDA to facilitate the clinical development and expedited review of drugs intended to treat serious conditions and address unmet medical needs. According to regulations, drug candidates granted FTD status will have increased opportunities for communication with the FDA during subsequent drug development and review processes, which can help accelerate the drug's further development and approval for market entry.

Harbour BioMed Announces Submission to the National Medical Products Administration

Resubmission of Batoclimab Treatment

Biologics License Application for Generalized Myasthenia Gravis

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, announced that it has resubmitted the Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for its investigational drug Batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). According to the clinical trial protocol, Harbour BioMed has successfully completed the extension study of the Phase III clinical trial, collecting more long-term safety data without recruiting new patients. Therefore, the company voluntarily included this batch of safety data and resubmitted the BLA for Batoclimab as planned.

Hemei Pharma PDE4 Inhibitor

Proposed for Priority Review

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that the Mometasone Tablet (Hemay005 Tablet), submitted by Hemay Pharmaceutical, is proposed to be included in the priority review for the indication of moderate to severe plaque psoriasis. Public information indicates that this is a small molecule PDE4 inhibitor independently developed by Hemay Pharmaceutical. As a member of the PDE family, PDE4 can regulate the production of pro-inflammatory and anti-inflammatory cytokines through the specific hydrolysis of cAMP, thereby exerting a series of effects. Currently, researchers are developing PDE4 inhibitors for the treatment of various inflammatory diseases, including psoriasis, ankylosing spondylitis, atopic dermatitis, rheumatoid arthritis, systemic lupus erythematosus, etc. Globally, multiple PDE4 inhibitors have been approved for marketing. Hemay Pharmaceutical is a pharmaceutical company dedicated to the independent research and industrialization of innovative drugs globally. Its R&D pipeline covers autoimmune diseases, oncology, and other fields. To date, it has successfully completed the screening of dozens of new compounds, with over 10 indications for five core Class 1 innovative drugs having completed or currently undergoing clinical trials, and several indications already in pivotal clinical trial stages. In February 2023, the company announced the completion of nearly 300 million yuan in Series D financing.

Innovent Bio Announces Clinical Data for the First Time

Demonstrate BIC Potential

On June 1, 2024, Yilian Biologics reported the clinical data of YL202 in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. This marks the first public disclosure of clinical data since the company's establishment. YL202 is an ADC targeting HER3, designed based on Yilian’s TMALIN platform. Compared to U3-1402, the globally leading HER3 ADC drug in development, Yilian’s YL202 is expected to demonstrate Best-in-class and First-in-disease potential. In terms of response rate, the overall ORR for YL202 across all dose escalation cohorts was 42.3%, with an ORR of 60.0% at the 3.0mg/kg dose. By indication, the ORR for YL202 in EGFRm NSCLC across all dose escalation cohorts was 39.4%, while the ORR in HR+/HER2- BC was 53.8%. These figures significantly outperformed U3-1402’s corresponding results (non-head-to-head comparison). For the EGFRm NSCLC indication, where U3-1402 is nearing marketing application submission, the ORR was 29.8% and PFS was 5.5 months. Regarding breast cancer, Daiichi Sankyo has not prioritized U3-1402 (possibly due to strategic considerations given their DS-8201 and Dato-Dxd assets). According to publicly available information, YL202 has already initiated Phase II clinical trials for HR+/HER2- BC, positioning it to potentially take the lead globally. Previously, Yilian Biologics entered into an overseas collaboration and licensing agreement with BioNTech for this product. BioNTech paid Yilian Biologics an upfront payment of $70 million and a potential total payment exceeding $1 billion, securing exclusive rights to develop, manufacture, and commercialize YL202 outside of China.

Sinopro Cryoablation System

Animal Experimental Results First Published in the United States

Synaptic Medical recently announced that the new second-generation cryoablation system, Nordica, developed by its U.S. innovation research center, has shown positive results in animal experiments. The experimental results were first published online in the Journal of Interventional Cardiac Electrophysiology. Nordica has improved the design of the cryoballoon and circular mapping catheter. The balloon adopts a single-layer polyurethane design, with adjustable size, maintaining low and constant pressure inside the balloon during the freezing process. The purpose of this animal experiment was to verify the safety and effectiveness of the Nordica cryoablation system. Currently, Nordica has entered human clinical trials in the United States, with patient enrollment expected to be completed by September 2024. It is anticipated to launch in Europe in 2024, followed by synchronized launches in China, the United States, and Japan in 2025.

Innostellar Biotherapeutics RSV mRNA Vaccine

Granted Clinical Trial Approval in China

June 5, 2024, Hong Kong, Shenzhen, Nanjing — Innorna, a clinical-stage biopharmaceutical company focused on lipid nanoparticle (LNP) delivery technology and the development of innovative RNA therapies, announced that the Investigational New Drug (IND) application for IN006, its self-developed world’s first bivalent Respiratory Syncytial Virus (RSV) mRNA vaccine, has received tacit approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

IN006 is a bivalent RSV preventive vaccine product developed by Innovent Bio based on its proprietary mRNA-LNP technology platform. It can cover both RSV-A and RSV-B subgroups and may offer better broad-spectrum protection compared to monovalent vaccines. IN006 received IND approval from the U.S. Food and Drug Administration (FDA) in January 2024. The recent IND approval from the CDE marks another significant milestone for IN006. IN006 is the first China-produced RSV vaccine product to receive clinical trial authorization in China, and it is also the first non-COVID mRNA preventive vaccine product approved for clinical trials domestically.

Innovent Bio Expands in New Jersey, USA

Plasmid DNA and Viral Vector Production Capacity

Accelerate Cell and Gene Therapy Delivery

Leading Global Contract Development and Manufacturing Organization (CDMO) Vigor Bio announces the official opening of its plasmid DNA and viral vector production facility in Hopewell, New Jersey, USA. This state-of-the-art facility will serve as the core of Vigor Bio's operations in North America, accelerating the delivery of cell and gene therapies and laying a solid foundation for the company’s rapid global growth. The Hopewell facility spans approximately 128,000 square feet, including offices, laboratories, and production areas, equipped with the most advanced equipment and technology, focusing on process development and cGMP production of plasmid DNA and viral vectors (such as adeno-associated virus, lentivirus, and retrovirus). The facility supports technology transfer, process development, analytical method development, and the production of clinical and commercial GMP plasmid DNA and viral vectors.

Puyi Bio Xiangtong® Fully Degradable

Nasal Sinus Drug Stent System Receives International Recognition Again

Colombia Registration Approved

Puyi (Shanghai) Biotechnology Co., Ltd. has made another breakthrough in the field of pharmaceutical innovation, successfully obtaining marketing approval from Colombian authorities on May 31, 2024, for its Xiangtong fully degradable sinus drug-eluting stent system. The product's registered name is "Drug-eluting sinus absorbable stent system/Sistema de stent liberador de fármacos absorbible de senos paranasales." This marks the fourth overseas registration certificate obtained by Puyi Bio after Indonesia, the Philippines, and Thailand. The Xiangtong® Fully Degradable Sinus Drug-Eluting Stent System is a high-tech medical device independently developed by Puyi Bio, specifically designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS). After review by INVIMA, the product was found to comply with market access regulations, signifying a further enhancement of Puyi Bio’s international influence in the medical device sector.

Hailai New Materials Approved for the First Time

Class III Medical Device License

Jiangsu Hailai Xinchuang Medical Technology Co., Ltd. has been granted its first Class III medical device registration certificate (Registration No.: National Medical Device Approval 20243031000) for a disposable intracranial retraction and fixation catheter. This series of products primarily provides a minimally invasive surgical channel for surgeries related to cerebral hemorrhage, brain tumors, and cerebrovascular diseases, helping to reduce postoperative recovery time for patients. Hailai Xinchuang will continue to increase R&D investment and launch more new products with higher product quality and better services, contributing to the medical industry in China.

Tianxing MedicalAll-sutureMeniscus Suture System

Approved for Marketing

Recently, the "All-Suture Meniscus Repair System" independently developed by Tianxing Medical received NMPA approval for marketing (Registration Certificate No.: Guo Xie Zhu Zhun 20243131059). Tianxing Medical has exclusively and first launched the all-suture meniscus repair system in China's domestic sports medicine industry, once again setting an industry benchmark. As a leader in China-produced sports medicine, Tianxing Medical is committed to providing comprehensive clinical solutions for sports medicine. The company has a total of nine sports medicine products that were the first to be approved and marketed by the National Medical Products Administration (NMPA). The company’s powered devices and consumables include endoscopic camera systems, endoscopic surgical shavers, plasma surgical equipment, and associated disposable shaver blades, electrodes, and other consumables intended for use together. The company's products have entered over 500 tertiary and higher-level hospitals, establishing a broadly covered marketing network.

Stellar Sea Medical Disposable Electronic Endoscope

Approved CE-MDR Certificate

Recently, following the successive attainment of NMPA and FDA market approval for its disposable endoscope products, StarSea Medical’s BubbleView® Disposable Digital Flexible Cystoscope received 510(k) clearance from the U.S. Food and Drug Administration on June 10, 2024, and is now ready to launch in the North American market. As BubbleView® is a single-use product, surgeons use a brand-new cystoscope for each procedure, eliminating the risk of cross-infection and the need for reprocessing. This not only reduces healthcare costs associated with cleaning supplies, maintenance, and repairs but also minimizes staff exposure to reprocessing chemicals. Additionally, BubbleView® seamlessly integrates with MacroLux's cutting-edge monitoring platform, the ViewHub® S13 Portable Video Processor. This portability facilitates internal consultations by physicians, enhancing teamwork and communication efficiency. Established in October 2020, StarSea Medical is an innovative medical technology enterprise specializing in the research, development, production, sales, and service of disposable endoscopic interventional diagnosis and treatment solutions. Its product portfolio covers urology, ICU, gynecology, emergency medicine, and anesthesia.

Duchem Analytical Testing Center

Awarded CNAS Laboratory Accreditation Certificate

Recently, the Analytical Testing Center of Dooch (Shanghai) Pharmaceutical Development Co., Ltd. has officially obtained the CNAS laboratory accreditation certificate from the China National Accreditation Service for Conformity Assessment (CNAS), with the registration number: CNAS L20914. The accredited scope of capabilities includes 17 testing abilities related to chemical drugs (active pharmaceutical ingredients), such as impurities, content determination, identification, elemental analysis, and residual solvents. The acquisition of the CNAS laboratory accreditation certificate indicates that the Analytical Testing Center of Dooch (Shanghai) Pharmaceutical Development Co., Ltd. has reached a management level and testing capability that comply with international standards. The hardware facilities, personnel capabilities, and management systems of the Analytical Testing Center conform to the relevant criteria and norms of ISO/IEC 17025.

Harbour BioMed Partners with BioMap to Sign Strategic Cooperation Agreement

Accelerate the Development of Bio-computing to Seize the First-mover Advantage

On June 24, Hong Kong Investment Management Limited (HKIM) signed a strategic cooperation agreement with BioMap. HKIM will provide comprehensive resource matching and support for BioMap’s subsequent development in Hong Kong, promoting Hong Kong as an international bio-computing hub. This marks the second strategic partner announced by HKIM within two weeks, reflecting its full-speed efforts to drive the development of Hong Kong's innovation and technology ecosystem through investment. On the same day, BioMap announced the establishment of its first international innovation center (BioMap InnoHub) in Hong Kong, aiming to attract global innovative forces and fully nurture local technology teams to jointly accelerate the construction and development of Hong Kong’s AI for Life Science ecosystem. The University of Hong Kong, the Hong Kong University of Science and Technology, Hong Kong Cyberport, and the Hong Kong Science and Technology Parks Corporation attended the inauguration ceremony of the Innovation Center as BioMap’s ecosystem partners. The first project implemented at the Innovation Center is the "Bio-Computing Innovation Acceleration Program" (BioMap BioX), which is expected to support more than 50 cutting-edge early-stage life science R&D projects over the next five years, with priority given to projects recommended by Hong Kong universities and ecosystem partners.

AccuraBio and LePure Bio

Jointly Release New HEK293 Cell Line Products

Empower the Industry Together

On June 15, Hangzhou Xingcheng Biotechnology Co., Ltd. (hereinafter referred to as "Xingcheng Bio") and LePure Biotechnology Co., Ltd. (hereinafter referred to as "LePure Bio") held a lunch conference for the launch of their new HEK293 cell bank at the 2024 China Gene and Cell Therapy (CSGCT) Summit. At the conference, Xingcheng Bio and LePure Bio jointly released their co-developed GMP version of the HEK293 cell bank. The release of this product aims to provide gene and cell therapy companies with more efficient, stable, and cost-saving production cell line support, empowering industry development. The launch of the HEK293 cell bank will open a new chapter of collaboration in the industry, not only enhancing the production efficiency of gene and cell therapy companies but also promoting industrial upgrading. Through the joint efforts of both parties, the HEK293 cell bank is expected to become an industry benchmark, providing strong support for the research and production of gene and cell therapy products.

Abogen Biosciences and Ruijin Hospital

Sign a Strategic Cooperation Agreement

On June 6, Abogen Biosciences and Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine (hereinafter referred to as "Ruijin Hospital") held a strategic cooperation agreement signing ceremony to further promote the application of mRNA technology in clinical settings, and accelerate the transformation of scientific research achievements and the development of new products. Dr. Ying Bo, founder, chairman, and CEO of Abogen Biosciences, stated that Ruijin Hospital’s excellent medical talent team, along with its advanced medical equipment and technology, has provided a solid platform for the application and practice of Abogen Biosciences' new technologies. Currently, the two parties have already launched collaborations in multiple fields such as oncology, with more clinical trials set to begin soon. Dr. Ying Bo said that this strategic cooperation in cutting-edge fields is not only of strategic significance to Ruijin Hospital and Abogen Biosciences but will also further enhance Suzhou's influence in China’s and even the global biopharmaceuticals industry, demonstrating leading, flagship, and exemplary effects.

Giant Yi Technology and Aipeng Medical

Sign a Strategic Cooperation Agreement

Deepen the Full Life Cycle Cooperation of Medical Devices

On June 17, a strategic cooperation signing ceremony between Jiangsu Aipeng Medical Technology Co., Ltd. and JoyMed Technology (Shanghai) Co., Ltd. was held at the JoyMed Technology Research and Development Center in Pujiang Wisdom Plaza. Through this strategic agreement, Aipeng Medical and JoyMed Technology will focus on various aspects of the entire lifecycle of medical devices as the foundation, leveraging their respective advantageous resources to establish a strategic cooperation framework. Through this collaboration, both parties aim to promote the common development of their enterprises, strengthen in-depth cooperation in their businesses, jointly address new challenges in the external environment, and contribute to the healthcare industry.

ClinChoice Kunling Becomes

The First Affiliated Hospital of Zhejiang University School of Medicine

The First Clinical Research Strategic Cooperation CRO

Recently, the "2024 Clinical Research Cooperation and Exchange Conference of the First Affiliated Hospital of Zhejiang University School of Medicine" was held. During the conference, the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as "FAHZU") and ClinChoice Kunling reached a "Star Site" Lingyao - Medical-Enterprise Clinical Research Strategic Cooperation Agreement. ClinChoice Kunling is the first Contract Research Organization (CRO) company to establish a strategic partnership with FAHZU. FAHZU has long been renowned both domestically and internationally for its strong comprehensive capabilities, high-quality medical services, and distinctive disciplinary strengths, consistently ranking among the top tier in overall strength. As the first strategic cooperation institution in Zhejiang and the second in East China, this signing marks another significant milestone in ClinChoice Kunling’s "Star Site" Lingyao - Medical-Enterprise Clinical Research strategic deployment. Moving forward, the two parties will closely collaborate, guided by clinical needs, to focus on promoting innovative research and the transformation of scientific achievements.

Safu Pharmaceuticals and Guotong New Drug Join Forces

Build an End-to-End CR/DMO

One-stop Radiopharmaceutical Service Platform

Wuxi Saifu Guotong Pharmaceutical Technology Co., Ltd. is a joint venture established by Beijing Saifu Pharmaceutical Research Institute Co., Ltd. and Guotong (Chengdu) New Drug Technology Co., Ltd. It is a one-stop R&D technical service company that possesses the qualifications for the use of various medical radionuclides and provides specialized technical services such as CDMO, pharmacology/toxicology, innovative drug isotope molecular imaging, and mass balance studies for radiopharmaceuticals in compliance with GLP regulations from regional/regulatory agencies like the FDA, NMPA, and OECD. Wuxi Saifu will have the service capability of a Grade B unsealed radioactive material workplace qualification, enabling it to handle 40 types of radioactive isotopes including 18F, 68Ga, 177Lu, 89Zr, 131I, 99mTc, 14C, and 125I, providing professional and reliable one-stop services for radiopharmaceutical and innovative drug development companies. Saifu Pharmaceutical and Guotong New Drug jointly established a radiopharmaceutical evaluation and radioactive molecular imaging service platform. Through this joint venture, they aim to further strengthen their cooperative relationship, achieve complementary advantages, innovative development, resource sharing, and mutually beneficial cooperation.

Harbour BioMed HBM1020

Awarded the 2024 Drug Innovation Ji Shi Award

"Annual Drug Innovation Pioneer Award"

Recently, the winners of the "Fourth Drug Innovation Jishi Award," selected by the Securities Times, were announced. HBM1020, a first-in-class, fully human monoclonal antibody targeting B7H7 (also known as HHLA2) developed by Harbour BioMed, won the "Annual Drug Innovation Pioneer Award." This marks the second consecutive year that Harbour BioMed has received this award. HBM1020, which was developed using the Harbour Mice® H2L2 transgenic mouse platform, is the world’s first monoclonal antibody targeting B7H7/HHLA2 to be formally approved for clinical trials. Currently, HBM1020 is undergoing Phase I clinical trials globally, and Harbour BioMed is accelerating its clinical development efforts to fully unlock the potential and value of this potential first-in-class product, aiming to bring meaningful therapeutic benefits to patients with advanced malignant tumors.

Innostellar Biotherapeutics Co., Ltd. Selected for 2023 Annual

Top 20 in Pharmaceutical Cold Chain Transportation Capacity

Recently, the 2024 13th International Conference on Cold Chain Pharmaceutical Supply Chain was held in Qingdao. At the conference, the top 20 pharmaceutical cold chain transportation capabilities for 2023 were announced, with Shengsheng Logistics successfully making the list. According to the requirements of the National Development and Reform Commission and the China Federation of Logistics and Purchasing's "Social Logistics Statistical Accounting and Reporting System," the Pharmaceutical Logistics Branch of the China Federation of Logistics and Purchasing conducted a statistical survey on enterprises' pharmaceutical cold chain transportation capabilities and carried out the selection for the top 20, aiming to discover and honor outstanding performers in the industry. Shengsheng has received this honor for five consecutive years. At this conference, Shengsheng was also awarded the "National Standard Demonstration Enterprise for the Operation Standards of Pharmaceutical Cold Chain Logistics."