近日，普洛药业下属子公司浙江普洛家园药业有限公司的氘恩扎鲁胺原料药境内生产化学原料药上市申请获得国家药品监督管理局批准。此次获批，标志着由普洛药业承接的这款创新药CDMO原料药项目顺利完成注册，可为合作客户提供合规、稳定的原料药供应，进一步保障海纳安?（氘恩扎鲁胺软胶囊）商业化生产需求。
作为海创药业的CDMO合作伙伴，普洛药业负责该制剂原料药的供应，为产品商业化提供稳定合规的原料支撑。多年来，双方保持深度、稳定的战略合作关系，凭借严苛的质量管控、成熟的生产工艺和稳定的交付能力，公司已连续三年获评海创药业年度优秀合作供应商，充分彰显了客户对公司CDMO综合服务能力的高度认可。
此次氘恩扎鲁胺原料药顺利获批，体现了普洛药业在CDMO业务研发、规模化生产、质量体系保障等方面的综合能力，也将进一步完善公司创新药原料药产品布局，为该药持续稳定供货筑牢合规基础。
未来，普洛药业将持续深耕CDMO赛道，聚焦创新药产业化核心需求，持续以高品质、高标准的定制研发生产服务，助力合作伙伴推动创新药落地，让更多优质临床药物惠及患者。
Apeloa Pharmaceutical Secures NMPA Approval for Deutenzalutamide API, Expanding Its CDMO Capabilities Across the Innovative Drug Value Chain
Apeloa Pharmaceutical recently announced that Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., one of its subsidiaries, has received approval from China''s National Medical Products Administration (NMPA) for the Marketing Authorization Application (MAA) of its domestically manufactured deutenzalutamide active pharmaceutical ingredient (API).
The approval marks the successful completion of regulatory registration for this innovative-drug CDMO API project undertaken by Apeloa. It enables the company to supply compliant, reliable API volumes to its partner, ensuring stable commercial production of deutenzalutamide soft capsules.
As the CDMO partner of Hinova Pharmaceuticals, Apeloa is responsible for supplying the API for this drug product, underpinning its commercialization with stable, compliant supply. The two companies have maintained a deep, stable strategic partnership over the years. Driven by Apeloa''s stringent quality control, mature manufacturing processes, and reliable delivery capabilities, the company has been named Hinova''s "Annual Excellent Supplier" for three consecutive years — reflecting Hinova''s strong recognition of Apeloa''s comprehensive CDMO capabilities.
The approval of the deutenzalutamide API demonstrates Apeloa''s integrated strengths in CDMO R&D, commercial-scale manufacturing, and quality system assurance. It will also further enrich the company''s portfolio of innovative-drug APIs and secure the regulatory foundation for sustained, stable supply of this medicine.
Going forward, Apeloa will continue to deepen its commitment to the CDMO space, focusing on the core needs of innovative drug commercialization. By delivering high-quality, customized R&D and manufacturing services, the company will help its partners bring innovative medicines to market — making quality therapies accessible to more patients.