Chime Biologics Ltd.

• 加速推进Polpharma Biologics生物类似药项目从IND至商业化生产阶段• 鼎康生物承诺为Polpharma Biologics的美国FDA 及欧盟EMA BLA申请提供生产支持• Polpharma Biologics计划将该产品拓展至全球市场2025年4月16日，波兰格但斯克和中国上海 – 全球领先的CDMO公司鼎康生物（Chime Biologics），今日宣布与波兰Polpharma Biologics达成战略合作协议，共同推进一款生物类似药的全球市场开发和生产。此次合作彰显了鼎康生物致力于提供高质量、高性价比生物制品的承诺，进一步巩固其在欧洲的市场地位。根据协议，鼎康生物将为Polpharma Biologics提供从临床试验用新药（IND）申请到商业化生产的生物类似药开发全流程支持。满足全球供应需求Polpharma Biologics是全球生物类似药市场的重要参与者，也是波兰最大的生物技术公司，拥有丰富的产品研发管线，涵盖多个早期和后期生物类似药项目，以及两款已经获得FDA/EMA批准的生物类似药产品。凭借在生物类似药开发与生产领域的丰富经验，鼎康生物已蓄势待发，全力满足全球市场对生物类似药日益增长的需求。依托真正的一站式服务，鼎康生物凭借行业领先的细胞株开发、工艺开发和分析方法开发能力，以及持续拓展的产能和全面的法规支持，为客户提供从IND申请到商业化生产供样的高效、快速的CMC开发服务，助力客户产品加速进入市场。与鼎康生物的合作契合我们快速将欧洲开发的可负担生物类似药推向全球市场的战略愿景。通过与鼎康生物合作，我们能够加速患者获取生物类似药治疗的机会。此次合作进一步巩固了Polpharma Biologics作为领先的生物类似药开发者的全球地位，同时借助亚洲合作伙伴的优势，实现成本效益的优化。我们非常高兴能够为Polpharma Biologics的发展贡献力量，通过提供一体化解决方案，加速生物类似药的开发并缩短上市时间。此次合作进一步强化了我们向全球患者提供高质量、可负担的生物制品的战略目标。Polpharma Biologics是一家国际生物技术公司，在欧盟（EU）拥有整合运营，专注于开发和生产生物类似药。公司致力于开发用于治疗主要治疗领域多种疾病的生物类似疗法。从细胞株开发起步，Polpharma Biologics的项目依次经过技术开发、临床开发，最终过渡到商业化规模生产，为与全球制药组织建立未来商业合作伙伴关系做好准备。公司目前生产其研发管线中的两款已获批的生物类似药：雷珠单抗（ranibizumab）和那他珠单抗（natalizumab）。Polpharma Biologics在荷兰设有细胞株开发中心，在波兰设有两个开发和生产中心，为生物技术专家创造了广阔的发展机会。如需了解更多信息，请访问：https://polpharmabiologics.com/en/。鼎康生物是一家全球领先的CDMO公司，率先引进了全球首个模块化生物制药工厂KUBioTM，赋能生物制品从细胞株开发到商业化生产的全过程。我们位于上海的创新中心聚焦高效的细胞株开发和先进的技术开发，与拥有多国临床试验申请和新药上市成功经验的武汉制造工厂相结合，鼎康生物正在为全球生物医药客户提供一站式的CMC解决方案。在鼎康生物,我们有一个共同的目标, 致力于提高前沿生物医药对全球患者的可及性，履行我们对人类健康的承诺。如需了解更多信息，请访问：www.chimebiologics.com。

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Bayer has opened its $44 million 70,000-square-foot expansion at its Myerstown, PA, facility, the company said Wednesday. The site manufactures products for Bayer’s consumer health business. A new mid-size CDMO called Meribel Pharma Solutions launched on Tuesday, according to a release on the same day. The new company will operate out of 10 manufacturing sites, seven of which it bought from Recipharm last year, and three research and development facilities in Europe. Ginkgo Bioworks has secured a $29 million two-year contract with Advanced Research Projects Agency for Health along with other companies including Tritica Biosciences, US Pharmacopeia, On Demand Pharmaceuticals and Isolere Bio by Donaldson. The project is intended to establish a new manufacturing process for APIs using wheat germ cell-free expression tech, according to a release on April 10. CDMO Chime Biologics has partnered with Polpharma Biologics to manufacture an unnamed biosimilar, according to a Wednesday release. Cell therapy biotech Atelerix has teamed up with China-based logistics company MineBio, which will distribute Atelerix’s products in China, the companies said Tuesday. FesariusTherapeutics has partnered with Regenity Biosciences who will manufacture FesariusTherapeutics’ collagen-based dermal regeneration templates used to treat patients with wounds, according to a Thursday press release. Renal disease-focused Rege Nephro has acquired clinical and non-clinical assets related to the chemical tamibarotene from Syros Pharmaceuticals, the company said Tuesday. The deal closed on Feb. 26. Clinical-stage INmune Bio has partnered with UK-based CGT Catapult to establish commercial manufacturing for its cell therapy technologies, according to a Monday release. Kyowa Kirin has completed the construction of its new 16.8 billion Japanese yen ($118 million) drug substance manufacturing site in Takasaki, Japan, the company said on Apr. 11.

Accelerate Polpharma Biologics biosimilar program from IND to commercial manufacturing Includes a commitment to producing for US FDA BLA submission Expand global market presence through launch in EU and other regions GDAŃSK, Poland and SHANGHAI, April 16, 2025 /PRNewswire/ -- Chime Biologics, a leading global CDMO that enables its partners' success in biologics, is pleased to announce a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and manufacture of a biosimilar product for the global market. This partnership underscores Chime Biologics' commitment to delivering high-quality, cost-effective biologics and further strengthening Chime Biologics' presence in Europe. Under this agreement, Chime Biologics will provide Polpharma Biologics with end-to-end support for a biosimilar development, spanning from investigational new drug (IND) to commercial supply. Meeting Global Supply Needs Polpharma Biologics, a major player in the global biosimilar market and the largest biotechnology company in Poland, brings a robust pipeline that includes multiple early-stage and late-stage biosimilars, along with two FDA/EMA-approved biosimilar products. With an extensive track record in delivering biosimilars for global markets, Chime Biologics is well-positioned to meet the growing global demand for biosimilars. Through Chime's true end-to-end offerings, from our state-of-the-art cell line, process and analytical development capabilities, expanding manufacturing capabilities and regulatory support activities, Chime Biologics offers clients fast-tracked CMC development to commercial supply to ensure fast market entry for our clients. "We are thrilled to contribute to Polpharma Biologics' growth as we provide all-in-one solutions to accelerate biosimilar development and reduce the time-to-market," said Dr. Jimmy Wei, President of Chime Biologics. "This collaboration reinforces our strategy of delivering high-quality, affordable biologics to patients worldwide." "Partnering with Chime Biologics supports our strategic vision to swiftly bring affordable biosimilars developed in Europe to global markets," said Konstantin Matentzoglu, Member of the Supervisory Board of Polpharma Biologics Group BV. "By working with Chime Biologics, we can accelerate patient access to biosimilar therapies. This partnership further strengthens Polpharma Biologics' global position as a leading biosimilars developer, while leveraging Asian partners with optimized cost-benefit ratio". About Polpharma Biologics Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Under partnerships agreements, the company manufactures two approved biosimilars from its pipeline; ranibizumab and natalizumab. With its cell line development center in The Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates development opportunities for biotechnology specialists. For more information, please visit . About Chime Biologics Chime Biologics is a leading global CDMO, focused on ensuring its partners' success in delivering innovative biologics to the world. Chime Biologics is a biologics service provider, from pre-clinical support and cell line development to clinical and commercial manufacturing of DS and DP. Employing our innovative and state-of-the-art development and manufacturing capabilities and proven success in supporting our clients with their clinical and commercial authorizations across the globe, Chime Biologics is a true end-to-end solution provider for the global biologics industry. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling our commitment to human health. For more information, please visit . Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED