Tobramycin

专访海正药业副总裁伍雄辉深耕三十余年 向国际化深水区进发在当今医药全球化的浪潮中，海正药业携三十余年国际化积淀亮相CPHI & PMEC China 2025。展会现场，制药在线记者有幸采访到海正药业副总裁伍雄辉先生。伍总分享了公司在质量管理和国际拓展方面的宝贵经验，并勾勒出海正药业未来的发展蓝图。希望能够为有心拓展国际市场的制药同仁带来诸多启发与思考。点击查看海正药业副总裁伍雄辉采访视频01制药在线：海正药业旗下三大生产基地（台州、南通、富阳）去年相继顺利通过FDA现场审计。您认为海正药业在质量管理体系方面有哪些优势，能够持续达到如此高的国际标准？伍雄辉：第一，历史厚度。海正拥有悠久的国际化历史积累，1992年就获得了第一个产品妥布霉素的FDA认证，团队经验丰富。第二，对标先进。在多年持续与高端客户的合作中，海正药业不断提升自身水平。第三，关注政策。我们紧跟国际合规的最新要求、不断强化对政策的理解。02制药在线：美国关税政策不仅影响中国也对全球制药供应链产生了冲击，您认为中国企业可以通过哪些举措来降低成本与风险？伍雄辉：对于这个话题我们可以进行一下探讨。第一，技术护城河。作为生产企业，我们要持续地优化降本，继续发挥我们的技术优势。第二，产品组合拳。优化产品组合，持续跟进新产品开发。第三， 市场多元化。地缘政治引起的关税挑战主要来自于美国，未来可能波及欧洲国家。海正药业在欧美市场长期耕耘，这些都是我们的优势市场。制药领域与人口息息相关，但全球大部分人口集中在欧美以外地区。接下来，海正药业可能在“一带一路”相关国家和地区拓展市场，通过市场多元化来分散风险。03制药在线：海正药业在国际化过程中，如何平衡不同国家和地区的市场需求和法规差异？伍雄辉：国际化是制药行业最大挑战之一。每个国家和地区都有自己的法规要求，市场规则和文化差异。为此，海正药业设立了五大国际市场区域，配备五个不同的团队，注册团队也按区域协作。这些团队有助于我们深耕一线，更深刻理解当地的法规、文化和市场规则等，从而制定相应的价格策略与注册策略。04制药在线：海正药业在海外市场如何通过本地化运营来提升品牌影响力和市场份额？伍雄辉：这非常重要。海正药业在早期中国医药行业国际化中处于领先地位。如今三十多年过去了，我们的国际化要走向深水区，提出2.0版本，就是在不同区域推进本土化建设，包括团队本土化，未来技术和生产在当地与合作伙伴进行深度绑定，这是我们对国际化2.0的一些设想。05制药在线：贵司会重点聚焦哪些潜力产品领域来拓展业务版图呢？伍雄辉：海正药业的强项还是在人用药及兽药相关的一些原料药产品，当然，还有国际制剂业务。我们在深耕基本盘的基础上，同时拓展大健康相关的营养品、食品添加剂及兽用添加剂等领域。06制药在线：未来几年、国际市场拓展方面，公司有哪些具体的规划和目标？伍雄辉：公司管理高层对国际业务提出了很高的要求，我们的目标可以从几个方面来看：1、每年至少两位数的业绩增长。2、提升团队素质。3、陆续建立海外本土团队。结语通过本次采访，我们对海正药业在国际市场的战略布局和未来发展方向有了更深入的了解。凭借其在质量管理体系、市场拓展和海外本地化运营等方面的优势，海正药业正稳步迈向国际化的深水区。我们期待海正药业在未来能够继续引领行业潮流，为全球患者带来更多优质的医药大健康产品。来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

Tetra-functional T-cell engagers activate T cells and simultaneously reduce immunosuppression, with potent and antigen-specific anti-pancreatic cancer activities at dose levels that are well tolerated Presentation at the Phoenix Best Science Series by HonorHealth Research Institute on June 27, 2025 in Scottsdale, Arizona MIRAMAR, Fla., June 27, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced today that its scientists have successfully developed second-generation, multi-specific T-cell engagers against solid tumors, particularly for pancreatic cancer, using its novel proprietary TRBC product discovery and development platform technology. The TRBC technology enabled the Company to construct T-cell engagers that not only target cancer antigens and CD3 activation of effector T cells, but also simultaneously reduce the immunosuppression in tumor microenvironment. Such immunosuppression plays a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. The Company’s two lead T-cell engagers target tissue factor and mesothelin, which are proven solid tumor antigens. These product candidates exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at dose levels that are well tolerated. Dr. Hing C. Wong, Founder and CEO of the Company, will present the details of these IND-enabling studies as an invited speaker for the Phoenix Best Science Series, hosted by HonorHealth Research Institute, located at HonorHealth Scottsdale Shea Medical Center in Scottsdale, Arizona, on June 27, 2025. Dr. Wong stated, “T-cell engagers revolutionized the immunotherapeutic approach against cancer. Currently, T-cell engagers have approval from the U.S. Food and Drug Administration to be used in the treatment of a small number of indications, including various hematological and solid tumors. Now, we are very excited to report that our proprietary TRBC product discovery platform can be used to create potentially highly effective T-cell engagers against difficult-to-treat solid tumors by using exceptional targets while managing immunosuppression. In our preclinical studies, after treatment with our TRBC-based T-cell engagers, there was 100% survival among tumor-bearing mice in the test group, whereas none of the untreated mice survived. We believe our approach could expand the number of indications that can be treated with T-cell engagers, including enhancing health span for patients suffering with solid tumors, especially diseases such as pancreatic cancer and glioblastoma.” Dr. Wong continued, “I am very honored to be invited to present at the Phoenix Best Science Series, organized by HonorHealth Research Institute, and join a renowned group of medical and research experts who are at the forefront of the treatment of pancreatic cancer. I look forward to sharing, with this esteemed group, our findings and the basis for our confidence in the potential of our innovative TRBC technology and its derived T-cell engagers against pancreatic cancer and other solid tumors. We believe we are at the cutting edge for expanding the indications that may be treated with T-cell engagers.” About HCW Biologics: HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-006, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/ Forward Looking Statements: Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the potential for a future transaction and sharing proceeds therefrom; the actual success and potency of T-cell engagers; whether T-cell engagers have antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at dose levels that are well tolerated; whether T-cell engagers are effective in treatment of solid tumors and pancreatic cancers. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025, the latest Form 10-Q filed with the SEC on May 15, 2025 and in other filings filed from time to time with the SEC. Company Contact: Dr. Peter Rhode Chief Scientific Officer and Vice President of Clinical Operations HCW Biologics Inc. PeterRhode@HCWBiologics.com