以下文章由RDPAC成员——默克供稿
2025年6月5日，德国达姆施塔特/中国昆山——全球领先的科技公司默克集团（Merck KGaA）宣布与苏州泽璟生物制药股份有限公司（以下简称“泽璟制药”）达成合作协议，德国默克获得泽璟制药自主研发的注射用重组人促甲状腺激素（rhTSH）在中国大陆地区的独家商业化权益。双方将整合默克的本土商业网络与泽璟制药的研发实力，加速填补国内甲状腺癌术后精准管理药物空白。 |
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默克中国医药健康董事总经理张巍表示：
“在中国，默克已深耕甲状腺疾病领域近30年，我们的两款甲状腺药物均属于指南推荐的首选药物类别，惠及了庞大的甲状腺疾病患者群体。此次合作是默克在甲状腺领域的商业化资源与本土创新力量的深度耦合，更是默克践行‘齐心为病患’理念、积极改善患者生命的又一里程碑。重组人促甲状腺激素（rhTSH）在中国大陆地区的获批和上市将填补国内甲状腺癌术后精准管理的药物空白，为患者带来全新的治疗选择。”
目前，中国患者仍长期依赖传统“甲状腺激素撤退疗法”以提升体内促甲状腺激素（TSH）水平，从而面临停药所致的甲减症状和潜在的肿瘤增殖风险。重组人促甲状腺激素（rhTSH）是泽璟制药自主研发的生物大分子药物，其结构与人体内源性TSH的氨基酸序列完全一致。该药物可在不停用甲状腺激素的情况下快速提升体内TSH水平，通过与甲状腺滤泡细胞或甲状腺肿瘤组织上的促甲状腺激素受体(TSHR)结合，刺激残余甲状腺组织和肿瘤组织增加摄碘和分泌甲状腺球蛋白（Tg），提升术后复发监测灵敏度，并可用于分化型甲状腺癌术后辅助放碘清甲治疗。同类治疗方案已在欧美市场广泛应用。2024年6月，国家药品监督管理局（NMPA）正式受理注射用重组人促甲状腺激素生物制品的上市许可申请（BLA）。
泽璟制药董事长、总经理盛泽林博士表示：
“甲状腺癌为中国最高发的恶性肿瘤之一，重组人促甲状腺激素（rhTSH）上市后将为甲状腺癌患者带来有效的术后管理方案 ，填补国内临床用药空白。默克作为深耕中国多年的国际型药企，具备优秀的商业化团队和丰富的新药推广经验，我们很高兴能与默克达成此次合作，期待在双方的合作之下，能够加速重组人促甲状腺激素的商业化进程，惠及广大患者、满足临床需求。”
关于默克
默克是一家全球领先的科技公司，专注于生命科学、医药健康和电子科技三大领域。全球有超62,000名员工服务于默克，通过创造更加愉悦和可持续性的生活方式，为数百万人的生活带来积极的影响。2024年，默克在65个国家/地区的总销售额达212亿欧元。
科学探索和负责任的企业精神一直是默克科技进步的关键，也是默克自1668年以来永葆活力的秘诀。默克家族作为公司的创始者至今仍持有默克大部分的股份，我们在全球都叫“默克”，仅美国和加拿大例外。默克的三大领域：医药健康、生命科学及电子科技在这两个国家分别称之为“EMD Serono”、“MilliporeSigma”和“EMD Electronics”。默克在中国已经有90余年发展历史，目前拥有近4,500名员工，在北京、上海、无锡、苏州、南通、香港等地拥有21家注册公司。
关于泽璟制药
苏州泽璟生物制药股份有限公司（股票代码：688266）成立于2009年，位于江苏省昆山国家高新区，拥有美国Gensun生物制药公司、上海泽璟医药技术有限公司、苏州泽璟生物技术有限公司、泽璟制药（浙江）有限公司和泽璟控股有限公司五个子公司。泽璟制药致力于创新药物的自主研发、生产和商业化。公司的目标是成为中国肿瘤、出血及血液疾病、免疫炎症性疾病和肝胆疾病等领域新药研发和生产的领军企业。公司的市场策略是面向全球，聚焦中国，研发和生产具有自主知识产权、安全、有效、患者可负担的创新药物，满足国内外巨大的医药市场需求。
Merck and Zelgen Biopharmaceuticals Forge Strategic Collaboration to Advance Commercialization of the Recombinant Human Thyroid-Stimulating Hormone Injection
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June 5th, 2025, Darmstadt,Germany/Kunshan,China—Merck,a leading science and technology company announced today that Merck,via its affiliate Ares Trading S.A., has entered into a collaboration agreement with Suzhou Zelgen Biopharmaceuticals Co., Ltd. (Zelgen) to obtain exclusive commercialization rights for Zelgen’s self-developed recombinant human thyroid-stimulating hormone (rhTSH) injection in Chinese mainland. This partnership leverages Merck's extensive local commercial network alongside Zelgen’s R&D capabilities to address the unmet need for precision postoperative management of thyroid cancer patients in China. |
Vivian Zhang, Managing Director of Merck China Healthcare, stated:
"Merck has been deeply engaged in the field of thyroid diseases in China for nearly 30 years. Our two thyroid products are both within the category of first-line treatments recommended by the Chinese guidelines, benefiting a large population of thyroid disease patients. This collaboration represents a profound integration of Merck's commercial expertise in the thyroid field with local innovative capabilities and marks another milestone in our mission of 'As One for Patients'."
Currently, Chinese patients still rely on traditional "thyroid hormone withdrawal therapy," which often results in hypothyroidism and suboptimal outcomes. Recombinant human thyrotropin (rhTSH) is a biologic drug independently developed by Zelgen, with an amino acid sequence identical to that of endogenous human thyroid stimulating hormone (TSH). It can rapidly increase TSH levels in the body without discontinuing thyroid hormone. This mechanism binds to thyrotropin receptors (TSHR) on thyroid follicular cells or thyroid tumor tissues. This stimulation enhances iodine uptake and thyroglobulin secretion from residual thyroid and tumor tissues, achieving therapeutic effects as adjuvant thyroid remnant ablation for differentiated thyroid carcinoma (DTC) after surgery and improving diagnostic sensitivity for monitoring postoperative recurrence.
rhTSH analogs have been widely used in Europe and the U.S. In June 2024, China’s National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for rhTSH.
Dr. Sheng Zelin, Chairman and CEO of Zelgen Pharmaceuticals, stated:
"Thyroid cancer is one of the most prevalent malignant tumors in China. The introduction of rhTSH will offer more effective postoperative management for patients, addressing the existing clinical gap in domestic medications. Merck, as an international pharmaceutical company with a long-standing presence in China, has a proven commercial team and extensive experience in promoting novel drugs. We are pleased to establish this collaboration with Merck and are confident that our partnership will accelerate the commercialization of rhTSH, ultimately benefiting patients and meeting critical clinical needs."
About Merck
Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck generated sales of € 21.2 billion in 65 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as Millipore Sigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.
About Zelgen
Founded in 2009, Suzhou Zelgen Biopharmaceuticals Co., Ltd. (China Shanghai: 688266) is located in the Kunshan National New & High-tech District (KSND) in Jiangsu Province, China. It is a joint venture with five subsidiaries: Gensun Biopharma Inc., Shanghai Zelgen Pharma-Tech Co. Ltd., Suzhou Zelgen Biosciences Co. Ltd., Zelgen Pharmaceuticals (Zhejiang) Co. Ltd. and Zelgen Holdings Ltd. Zelgen specializes in the research and development (R&D), manufacturing, and distribution of innovative medicines. Zelgen’s goal is to become a leading pharmaceutical company in China focusing on the areas of oncology, hematology, gastroenterology and auto-immune diseases. Zelgen’s market strategy emphasizes China, while expanding business opportunities internationally.
