1.2025年我国创新药获批实现高质量突破
2025年我国获批创新药76个,较2024年增长近六成,创下历史新高。其中国产创新药在化学药、生物制品中占比分别超80%和90%,对外授权总金额超1300亿美元,首创新药达11个(4个自主研发),标志着我国医药创新从跟随模仿迈入自主研发新阶段,深度融入全球创新链条。
In 2025, China approved 76 novel drugs, a historic high with a 60% increase. Domestic drugs dominated categories like chemical and biologicals, with overseas licensing exceeding $130B. This marks the industry's shift from imitation to self-driven innovation and deeper global integration.
2.英伟达与礼来共建AI药物研发联合实验室
2026年1月12日,摩根大通医疗健康大会上,英伟达与礼来宣布共建首个AI药物研发联合创新实验室。双方计划五年内投入10亿美元,结合礼来药物研发优势与英伟达AI技术,依托BioNeMo平台构建AI模型、生成大规模数据,加速药物研发进程。
Nvidia and Eli Lilly announced a first-of-its-kind AI drug discovery joint lab at the 2026 JPM Healthcare Conference. With a planned $1B investment over five years, they will leverage Lilly's R&D and Nvidia's AI via the BioNeMo platform to accelerate drug development.
3.荣昌生物与艾伯维达成RC148独家授权合作
2026年1月12日,荣昌生物与艾伯维就PD-1/VEGF双特异性抗体RC148签署独家授权协议。艾伯维获该药物大中华区以外地区的开发、生产及商业化权利,荣昌生物将获得6.5亿美元首付款及最高49.5亿美元里程碑付款,目前RC148正在中国开展晚期实体瘤临床研究。
On Jan 12, 2026, RemeGen and AbbVie signed an exclusive license for the bispecific antibody RC148. AbbVie obtains rights outside Greater China, while RemeGen receives $650M upfront and up to $4.95B in milestones. RC148 is currently in clinical trials in China for advanced solid tumors.
4.梅尔森贝美净获国内首张海外版药品价格证
2026年1月20日,国家医保局消息显示,梅尔森旗下贝美净(马来酸噻吗洛尔凝胶)获中国药品价格登记系统首张海外版价格证明。该药物用于治疗增殖期浅表性婴儿血管瘤,2025年9月获批上市,此次认证助力其快速拓展国际市场。
On Jan 20, 2026, the National Healthcare Security Administration issued China's first overseas pricing certificate to Melson's Bemezin gel for infantile hemangioma. The certification, following its September 2025 approval in China, will aid its international market expansion.
5. 先声药业与勃林格殷格翰达成全球合作,攻坚炎症性肠炎千亿赛道
2026年1月27日,先声药业与勃林格殷格翰达成12.54亿美元全球合作,聚焦自研TL1A/IL-23p19双抗SIM0709(用于炎症性肠炎治疗)。先声将获首付款及里程碑付款,享有海外净销售额特许权使用费,该药药效优于单药联用,彰显中国创新药BD出海实力及国际认可度。
On Jan 27, 2026, Simcere and Boehringer Ingelheim entered a $1.254B global collaboration for the bispecific antibody SIM0709 targeting IBD. Simcere will receive upfront and milestone payments plus royalties, showcasing the global recognition of China's innovative drug partnerships.
6. 阿斯利康计划2030年前在华投资逾1000亿元
2026年1月30日,阿斯利康宣布计划2030年前在华投资逾1000亿元人民币,扩大药品生产与研发布局。此次投资将增强其细胞治疗、放射偶联药物领域能力,升级无锡、泰州等多地生产基地,深化北京、上海研发中心布局,未来在华员工规模将超2万人,惠及癌症、血液病等患者。
On January 30, 2026, AstraZeneca announced plans to invest over RMB 100 billion in China by 2030 to expand production and R&D. The investment will enhance its cell therapy and ADC capabilities, upgrade production bases and R&D centers, with the goal of expanding its Chinese workforce to over 20,000.
7. 拜耳新型EGFR/HER2抑制剂获批,破解HER2 exon 20插入突变耐药困境
2025年11月,拜耳口服抑制剂Sevabertinib hydrate获FDA加速批准,针对EGFR/HER2突变肿瘤(含HER2 exon 20插入突变)。Ⅰ/Ⅱ期数据显示ORR达71%,DOR 9.2个月,为多线治疗失败患者提供精准新选择,破解耐药困境。
In November 2025, Bayer's oral inhibitor Sevabertinib hydrate received FDA accelerated approval for EGFR/HER2-mutated tumors (including HER2 exon 20 insertion). Phase Ⅰ/Ⅱ data showed an ORR of 71% and DOR of 9.2 months, providing a new option for patients with multi-line treatment failure.
8. 恒瑞医药两款ADC相继纳入突破性治疗品种,管线布局持续深化
近三月恒瑞ADC领域持续突破,c-Met ADC(SHR-1826)、CLDN18.2 ADC(SHR-A1904)相继被CDE纳入突破性治疗品种。依托自有DXh ADC平台,恒瑞已有1款ADC获批、4款进入Ⅲ期,巩固肿瘤创新领域优势。
In the past three months, Hengrui Medicine achieved continuous breakthroughs in ADCs, with c-Met ADC (SHR-1826) and CLDN18.2 ADC (SHR-A1904) successively included in CDE's breakthrough therapy designation. With its DXh ADC platform, Hengrui has 1 approved ADC and 4 in Phase Ⅲ, strengthening its advantage in tumor innovation.
9. 精准生物CAR-T产品获批,填补国内儿童白血病细胞治疗空白
2025年11月7日,精准生物普基奥仑赛注射液获NMPA获批,用于3~21岁CD19阳性难治/复发急性B淋巴细胞白血病。该药为国内首个、全球第二款该适应症CAR-T,Ⅱ期显示90.63%患者肿瘤被清除,填补国内儿童细胞治疗空白。
On November 7, Precision Bio's Puchiolense Injection was approved by NMPA for CD19-positive refractory/relapsed acute B-lymphoblastic leukemia in patients aged 3~21. As China's first and the world's second CAR-T for this indication, it achieved 90.63% tumor clearance in Phase Ⅱ, filling the gap in pediatric cell therapy in China.
10. 佐来曲替尼国内上市,重塑NTRK基因融合实体瘤治疗格局
2025年12月15日,国内首款自研新一代TRK抑制剂佐来曲替尼获批,用于NTRK基因融合实体瘤。临床显示ORR达89.1%,脑转移患者颅内ORR 100%,可克服一代耐药,为泛癌种精准治疗提供“中国方案”。
On December 15, 2025, China's first self-developed next-generation TRK inhibitor zolaletinib was approved for NTRK gene fusion solid tumors. Clinical data showed an ORR of 89.1% and 100% intracranial ORR in brain metastasis patients, overcoming first-generation drug resistance and providing a "Chinese solution" for pan-cancer precision treatment.
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供稿 | 滕昕辰
编辑|吴雨萱
审核|朱苏静、滕昕辰、夏心蕾、孙昊明