media – Page 9 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

IND Application for Targeted siRNA Drug FB7013 Accepted

Frontier Biotechnologies (688221) announced that on December 22, 2025, the company submitted an Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) for FB7013. Developed in-house, FB7013 is a targeted siRNA drug designed to inhibit MASP-2, a key protein in the lectin pathway of the complement system. On December 31, 2025, the company received the official notice confirming that the application has been formally accepted. FB7013 injection is intended for the treatment of primary immunoglobulin A nephropathy (IgAN) and possesses first-in-class potential. According to preclinical data, FB7013 demonstrated potent and long-lasting inhibition of the target protein in healthy cynomolgus monkeys, achieving a maximum knockdown rate of over 95%. In IgAN models, FB7013 showed significant efficacy, with dose-dependent improvements in both total urinary protein and glomerular filtration rate (GFR), alongside a favorable safety profile. In the first three quarters of 2025, Frontier Biotechnologies reported a revenue of 103 ...
- Source: drugdu
- 52
- January 4, 2026
Boston Scientific has changed its leadership in its core business!

According to recent foreign media reports, Boston Scientific (NYSE: BSX) will see a major personnel change in its cardiac rhythm management and diagnostics (CRMDx) business in 2026. Scott Olson, Senior Vice President and President of the business unit, announced on LinkedIn that he plans to retire at the end of 2025. Scott Olson, who has worked at Boston Scientific for 27 years , will be succeeded by Angelo De Rosa in early 2026 after his retirement . Angelo De Rosa is also a seasoned veteran of Boston Scientific, having joined in 2014 as Vice President of Marketing. In recent years, he has led the company’s Watchman left atrial appendage occluder business with outstanding results. Furthermore, it is worth noting that upon taking office, Angelo De Rosa will not only lead the CRMDx business but will also join the Boston Scientific Executive Committee. Angelo De Rosa stated that his career at ...
- Source: drugdu
- 80
- January 2, 2026
China Biopharmaceutical’s innovative drug TQH3906 completes Phase II clinical trial.

On December 29, China Biopharmaceutical (01177) issued an announcement stating that the Group’s independently developed Class 1 innovative drug…TQH3906, a “TYK2/JAK1JH2 allosteric inhibitor,” has recently completed its Phase II clinical trial for moderate to severe plaque psoriasis. Results showed that all dose groups of TQH3906 demonstrated good safety and tolerability, and met the primary endpoint of the Phase II study. The study enrolled 209 patients, including a placebo group and five different TQH3906 dose groups, with oral administration once daily. In terms of efficacy, TQH3906 showed a good dose-response relationship. At the recommended phase 2 dose, after 12 weeks of treatment, the PASI75 response rate exceeded 90% and the PASI90 response rate exceeded 70%, which was significantly better than the PASI75 and PASI90 response rates in the placebo group (approximately 10% and 5%, respectively). In terms of safety, TQH3906 has a good overall safety profile, with the overall incidence of ...
- Source: drugdu
- 78
- January 2, 2026
Transcenta Group-B and EirGenix Reach Biopharmaceutical Manufacturing Collaboration Agreement

On December 29, Transcenta Holdings Group-B (06628) announced a strategic collaboration and non-exclusive technology licensing agreement with EirGenix. The agreement aims to advance integrated continuous flow manufacturing of biopharmaceuticals and improve global accessibility to affordable biopharmaceuticals. Under the agreement, the company will grant EirGenix a non-exclusive license to its highly integrated continuous flow bioprocess manufacturing (HiCB) platform and provide complete process documentation, core process technologies and experience, and regulatory support services. The company will receive a substantial upfront payment and milestone payments, and will be able to collect future royalties related to the commercialization of the licensed technology. This collaboration is expected to significantly reduce production costs, enabling patients worldwide to access high-quality, affordable biologics. EirGenix plans to use the HiCB platform for its biologics development programs and manufacturing operations, supporting CDMO customers seeking highly integrated continuous flow manufacturing solutions. https://finance.eastmoney.com/a/202512293604195792.html
- Source: drugdu
- 72
- January 2, 2026
【EXPERT Q&A】What qualifications does a medical device company need to obtain?

Drugdu.com expert’s response: Medical device companies must obtain corresponding qualifications based on their business type (manufacturing or distribution) and product classification (Class I, II, or III). The details are as follows: I. Manufacturing Qualifications Class I Medical Devices Qualification Name: Class I Medical Device Production Filing Certificate Issuing Authority: Municipal-level drug regulatory administration (at the district level) Requirements: Possess compliant production facilities (e.g., cleanrooms) and equipment (e.g., calibrated instruments), along with quality management system documentation (e.g., quality manuals, work instructions). Submit materials including business license, proof of production site usage rights, and equipment inventory. Class II and Class III Medical Devices Qualification Name: Medical Device Manufacturing License Issuing Authority: Provincial drug regulatory administration (for Class II) or National Medical Products Administration (for Class III) Requirements: Production sites must meet cleanliness, temperature, and humidity standards, with advanced equipment subject to regular calibration. The quality management system must cover procurement, production, and ...
- Source: drugdu
- 60
- January 2, 2026
Jinghong Medical Secures Series A Strategic Financing, Co-led by Venture Capital and Binhu Industrial Group with FTEC Capital as Exclusive Financial Advisor

It was learned from Vcbeat on an exclusive basis that Jinghong Medical Technology Group, a flagship enterprise in the domestic medical sterilization and supply field, officially announced the successful completion of its Series A strategic financing recently. The financing round was jointly led by Wuxi Innovation Investment Group Co., Ltd. and Binhu Industrial Group, with follow-on investments from prestigious institutions such as Shanghai Digital Industry Group and Xiaoyar Capital. FTEC Capital acted as the sole financial advisor for this financing event. This milestone funding round not only embodies the capital market’s unwavering confidence in the medical sterilization and supply industry, but also indicates that Jinghong Medical has stepped into a new stage of accelerated development in its national chain deployment, technological upgrading and service scale expansion. Strong Rigid Demand in Sterilization & Supply Market, a Hundred-Billion-Yuan Sector According to the 2022-2028 Research and Development Prospect Report on China’s Third-party ...
- Source: drugdu
- 70
- January 1, 2026
Expofarma

Organiser：Mexican Pharmaceutical Association Time：April 15–17, 2026 Address：Conscripto 311, Colonia Lomas de Sotelo, Delegación Miguel Hidalgo, 11200, México D.F. Exhibition hall：Centro Banamex Product range: API (Active Pharmaceutical Ingredient) Equipment: Reaction equipment, drying equipment, crystallization equipment, centrifuges, extraction equipment, heat exchangers, storage equipment, filtration equipment, evaporation equipment, distillation equipment, screening machinery, sterilization equipment, filter press equipment, homogenizers, etc. Pharmaceutical Formulation Equipment: Pill-making machinery, ointment machinery, eye drop machinery, tablet machinery, tincture/syrup machinery, granule machinery, soft capsule (pill) machinery, aqueous injection machinery, hard capsule machinery, suppository machinery, oral liquid machinery, film-coating machinery, aerosol machinery, antibiotic powder/aqueous injection machinery, infusion machinery, tablet presses, coating machines, pharmaceutical filling machines, airflow pulverizers, pharmaceutical grinding mills, mechanical pharmaceutical crushers, ultrafine pulverizers, granulators, mixing equipment, bottle conveyors, bottle sorting machines, oscillating capping devices, feeding systems, etc. Pharmaceutical Packaging Machinery: Weighing equipment, bag packaging machines, pillow-type packaging machines, blister packaging machines, bottle filling lines, printers, labeling machines, cartoning ...
- Source: drugdu
- 70
- January 1, 2026
Harbour BioMed and Lannacheng Land Landmark Collaboration on Next-Generation RDC Drugs

December 29, 2025 — Harbour BioMed announced a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd. (Lannacheng). Leveraging their respective resources and strengths, the two parties will jointly advance the development of next-generation Radionuclide Drug Conjugates (RDCs). Compared with conventional radiotherapy, Radionuclide Drug Conjugates (RDCs) utilize tumor antigen-specific molecular ligands to precisely deliver radionuclides directly into tumor lesions for radiotherapy, thereby effectively minimizing damage to surrounding normal tissues. In contrast to Antibody-Drug Conjugates (ADCs), the radionuclides in RDCs can also exert cytotoxic effects on tumor cells adjacent to target cells and their microenvironment, even if these cells do not express the target antigen themselves. This confers a potential mechanistic advantage in overcoming tumor heterogeneity and drug resistance. Additionally, this technology holds promise for enabling theranostics (the integration of diagnosis and therapy). Harbour BioMed’s proprietary Harbour Mice® technology platform is capable of generating fully human monoclonal antibodies in both conventional ...
- Source: drugdu
- 76
- December 31, 2025
CAR-T Therapy Approved for Clinical Trials

On December 29, according to the official website of the Center for Drug Evaluation (CDE), Juventas Biotechnology’s HY001N cell injection has been approved for clinical trials, with the proposed indication being autoimmune hemolytic anemia (AIHA) that has failed at least three lines of therapy. It is worth noting that this is the company’s first CAR-T therapy developed based on its innovative, rapidly prepared NexT platform. CDE Official Website HY001N cell injection is the first product developed on Juventas innovative rapid NexT technology platform. Compared to traditional autologous CAR-T technology platforms, the rapid NexT process reduces the in vitro expansion and culture steps of CAR-T cells, shortening the in-plant production time from 9-14 days to less than 2 days. Patient waiting time is reduced by 50%, down to 10 days, and production costs are significantly lower than existing technologies. Simultaneously, the rapid CAR-T process significantly increases the proportion of T naïve cells in ...
- Source: drugdu
- 84
- December 31, 2025
The innovative anti-influenza drug, Mapaxixavir capsules (Yilikang®), was launched online on JD Health

On December 30th, Mapaxixavir Capsules (trade name: Yilikang®), a Class 1 innovative anti-influenza drug under Health-One Pharmaceutical Group, was launched online on the JD Health platform. This is an innovative oral treatment for influenza. Users can easily inquire and purchase it by searching for “Yilikang” on the JD APP, and quickly obtain cutting-edge antiviral treatment options. Influenza is an acute respiratory infectious disease caused by the influenza virus, and its harm is far greater than that of the common cold. Information released by the National Health Commission shows that influenza activity is currently at a high level nationwide. Influenza is highly contagious, has a rapid onset, and can cause symptoms such as high fever, body aches, and fatigue. It can also lead to serious complications such as pneumonia and myocarditis, posing a significant threat to the health of the entire population, especially children, the elderly, and patients with chronic diseases. ...
- Source: drugdu
- 80
- December 31, 2025

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