Deuterated enzalutamide

2025年上半年将尽，国家医保局近日发布《2025年国家基本医疗保险、生育保险和工伤保险药品目录及商业健康保险创新药品目录调整工作方案》等文件，公开征求意见，标志着本年度医保目录调整正式启动。值得关注的是，今年首次纳入商业健康保险创新药品目录制定，将进一步完善我国多层次医疗保障体系。 据不完全统计，2025年上半年国内至少有111款药物（含新适应症）获批上市。其中，抗肿瘤药物涉及23款，位居榜首；全身用抗感染药物（13款，11.7%）、消化系统及代谢药物（14款）、神经系统药物（13款）紧随其后，其余治疗领域获批药物均不足10款。 随着2025版医保目录调整推进，哪些抗肿瘤药物有望入选？全球肿瘤医生网小编特为广大癌友整理了一份“有望进入新版医保目录的抗肿瘤药物清单”，供癌友们参考收藏，以备不时之需。 一、2025有望进入新版医保目录的抗肿瘤药物全面盘点 （一）伊布替尼片 药品名称：伊布替尼片（Ibrutinib）。 研发公司：强生与艾伯维。 作用靶点：BTK。 适应症：慢性淋巴细胞白血病、套细胞淋巴瘤等。 药品详情 伊布替尼是一种高效、选择性的BTK抑制剂，同时也是全球首个获批上市的BTK抑制剂，在血液肿瘤治疗领域应用广泛。 2013年11月，伊布替尼胶囊获美国FDA批准上市，用于复发难治性慢性淋巴细胞白血病和套细胞淋巴瘤的治疗。2017年8月24日，伊布替尼正式获得中国食品药品监督管理总局批准，用于慢性淋巴细胞白血病及套细胞淋巴瘤的治疗。此外，2025 年 1 月 8 日，齐鲁制药（海南）有限公司按注册分类 3 类申报的伊布替尼片获批上市，为国内该剂型首仿。 （二）艾沙妥昔单抗注射液 药品名称：艾沙妥昔单抗（Isatuximab，Sarclisa） 研发公司：赛诺菲（Sanofi）。 作用靶点：CD38。 适应症：多发性骨髓瘤。 药品详情 艾沙妥昔单抗（Isatuximab，Sarclisa）是一种抗CD38单克隆抗体，2025年1月9日，艾沙妥昔单抗获中国国家药品监督管理局（NMPA）批准，与泊马度胺和地塞米松联合，用于成人既往接受过至少一线治疗（包括来那度胺和蛋白酶体抑制剂）的多发性骨髓瘤的治疗。此前（2024年9月20日）该药已获得美国FDA批准上市，与硼替佐米、来那度胺和地塞米松联合，用于成人、新诊断、且不适合进行自体干细胞移植(ASCT)的多发性骨髓瘤（NDMM）的治疗。 （三）塔奎妥单抗注射液 药品名称：塔奎妥单抗（Talquetamab）。 研发公司：强生。 适应症：多发性骨髓瘤。 药品详情 塔奎妥单抗（Talquetamab）是一种First-in-Class双特异性抗体和人源化单克隆抗体，同时也是一种CD3E调节剂。2025年2月11日，塔奎妥单抗获得中国国家药品监督管理局（NMPA）的上市批准，用于成人复发或难治性多发性骨髓瘤的治疗。此前（2023年8月9日）该药就已获得美国FDA的加速批准，用于成人既往已接受过至少4种治疗（包括免疫调节剂、CD38单克隆抗体、蛋白酶体抑制剂抗）的复发性或难治性多发性骨髓瘤的治疗。 Monumen TAL-1（NCT03399799）临床研究数据显示：在接受405μg和800μg剂量的塔奎妥单抗治疗组中，中位随访时间分别为11.7个月和4.2个月，患者的反应率分别为70%（95%CI：51~85）和64%（95%CI：48~78）（详见下图）；两组的中位缓解持续时间则分别为10.2个月和7.8个月。 ▲图源“N Engl J Med”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 （四）埃纳妥单抗注射液 药品名称：埃纳妥单抗（elranatamab）。 研发公司：辉瑞。 作用靶点：BCMA、CD3。 适应症：多发性骨髓瘤。 药品详情 埃纳妥单抗（Elranatamab，Elrexfio）是一种BCMA和CD3的双特异性抗体，旨在靶向在肿瘤细胞上高表达的BCMA和T细胞表面的CD3。2025年3月10日，该药获国家药品监督管理局（NMPA）附条件批准上市，用于既往接受过至少三线治疗（包括1种免疫调节剂、1种抗CD38单克隆抗体、1种蛋白酶体抑制剂）的复发或难治性多发性骨髓瘤（RRMM）成年患者的治疗。 本次获批主要基于一项MagnetisMM-3的2期临床试验(NCT04649359)数据，结果显示：客观缓解率（ORR）达61.0%（95%CI：51.8-69.6）。其中，35.0%的患者达到完全缓解（CR）或更优状态（≥CR）。此外，15个月时，Kaplan-Meier评估的无进展生存期（PFS）率为50.9%，中位总生存期（OS）率为56.7%。 （五）盐酸阿思尼布片 药品名称：盐酸阿思尼布片（Asciminib，Scemblix®，信倍立®）。 研发公司：诺华。 适应症：Ph阳性慢性粒细胞白血病。 药品详情 阿思尼布（asciminib）是一种针对慢性髓细胞白血病（CML）的靶向治疗药物，2025 年 5 月 14 日，获中国国家药品监督管理局批准，用于成人新诊断的费城染色体阳性的慢性髓细胞白血病（Ph+CML）慢性期（CP）的治疗。此前（2024年10月29日）获FDA批准，用于成人新诊断的费城染色体阳性慢性粒细胞白血病（Ph+CML）慢性期的治疗。 一项ASC4FIRST临床试验（NCT04971226）结果显示：阿思尼布的MMR（主要分子反应）率明显优于标准治疗，48周时的MMR率分别为68%（阿思尼布组） vs 49%[酪氨酸激酶抑制剂（IS-TKI组）]。 （六）氢溴酸他泽司他片 药品名称：他泽司他（Tazemetostat，Tazverik）。 研发公司：和黄医药。 作用靶点：EZH2。 适应症：滤泡性淋巴瘤、晚期上皮样肉瘤。 药品详情 他泽司他是一款口服的小分子EZH2抑制剂，2025年3月21日，该药获中国国家药品监督管理局（NMPA）批准，用于成人EZH2突变阳性且既往接受过至少两种系统性治疗的复发或难治性滤泡性淋巴瘤（FL）的治疗。 此前（2020年1月），他泽司他已获得美国FDA的加速批准，用于晚期上皮样肉瘤、复发/难治性滤泡性淋巴瘤的治疗，至此该药也成为了全球首款获批上市的EZH2抑制剂，具有里程碑式的重要意义！ （七）利厄替尼片 药品名称：利厄替尼片。 研发公司：江苏奥赛康药业。 作用靶点：EGFR。 适应症：非小细胞肺癌。 药品详情 利厄替尼是具有全新分子结构的第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），2025年4月25日，该药的新适应症上市申请在中国获批，适用于具有EGFR外显子19缺失（19DEL）或外显子21置换突变（L858R）的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。 （八）埃万妥单抗注射液 药品名称：埃万妥单抗注射液（锐珂®，Rybrevant，amivantamab-vmjw，代号为JNJ6372）。 研发公司：西安杨森。 作用靶点：EGFR-MET。 适应症：非小细胞肺癌。 药品详情 埃万妥单抗注射液是一种新型EGFR-MET双特异性抗体，可靶向激活及耐药的EGFR和MET突变与扩增，也是全球首款获批上市的EGFR/MET双特异性抗体。 该药的全球获批始于2021年5月，获美国FDA加速批准，成为全球首个针对该靶点的靶向疗法。2025年，在中国两度获批：2月11日首次获批，单药用于EGFR20号外显子插入突变（EGFR20ins）的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）一线治疗；4月25日再度获批，联合卡铂+培美曲塞，用于EGFR19号外显子缺失（19del）/21号外显子L858R突变且经EGFR-TKI治疗进展的局部晚期或转移性非鳞状NSCLC成人患者。 该药在中国获批主要基于一项MARIPOSA-2III期临床研究（NCT04988295））的关键数据！埃万妥单抗联合化疗组、埃万妥单抗联合拉泽替尼及化疗组的无进展生存期（PFS）均显著优于单纯化疗组，疾病进展或死亡风险分别降低52%和56%；经盲法独立中心审查，三组中位PFS分别为6.3个月（95%CI：5.6-8.4）、8.3个月（95%CI：6.8-9.1）和4.2个月（95%CI：4.0-4.4）。 （九）瑞康曲妥珠单抗 药品名称：注射用瑞康曲妥珠单抗（SHR-A1811）。 研发公司：恒瑞医药。 作用靶点：HER2。 适应症：局部晚期或转移性HER2阳性非小细胞肺癌。 药品详情 瑞康曲妥珠单抗（SHR-A1811）是一款HER2靶向的ADC药物，2025年5月29日，注射用瑞康曲妥珠单抗正式在中国获批上市，单药用于存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。 1/2 期临床研究（NCT04818333）结果显示：在所有63 名患者中，客观缓解率（ORR）达到38.1%（95% CI 26.1–51.2），中位PFS 为9.5个月（95% CI 7.1–11.7）。 （十）枸橼酸戈来雷塞片 药品名称：戈来雷塞片（glecirasib，JAB-21822，艾瑞凯®）。 研发公司：加科思。 作用靶点：KRAS。 适应症：KRAS G12C突变型晚期非小细胞肺癌。 药品详情 戈来雷塞片是加科思自主研发的一款KRAS G12C抑制剂。2025年5月22日，该药获得中国国家药品监督管理局药品审评中心（NMPA）批准正式上市，用于单药治疗至少接受过一种系统性治疗的KRAS G12C突变型晚期非小细胞肺癌（NSCLC）成人患者。 （十一）赛沃替尼 药品名称：赛沃替尼（savolitinib，沃瑞沙，ORPATHYS）。 研发公司：和黄医药。 作用靶点：MET。 适应症：非鳞状非小细胞肺癌。 药品详情 赛沃替尼是一款选择性MET抑制剂，用于治疗伴有MET外显子14 跳变的局部晚期或转移性非小细胞肺癌成人患者。 2025年6月30日赛沃替尼和奥希替尼（TAGRISSO，osimertinib）联合疗法的新药上市申请获中国国家药品监督管理局（NMPA）批准，用于治疗表皮生长因子受体（EGFR）基因突变阳性经EGFR酪氨酸激酶抑制剂（TKI）治疗后进展的伴MET扩增的局部晚期或转移性非鳞状非小细胞肺癌患者。 临床研究结果显示：沃瑞沙和泰瑞沙的联合疗法降低患者的疾病进展风险达66%，中位PFS为8.2个月，而化疗组则为4.5个月。 （十二）卡匹色替片 药品名称：卡匹色替片（Capivasertib，Truqap）。 研发公司：阿斯利康。 作用靶点：CDK4/CDK6。 适应症：HR阳性、HER2阴性的转移性/局部晚期乳腺癌。 药品详情 卡匹色替片（Capivasertib，TRUQAP）是一款AKT抑制剂，2025 年 4 月，2025 年 6 月 13 日，正式在中国获批上市，与氟维司群联合，用于成人转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后 12 个月内复发的HR阳性、HER2阴性，且伴有一种或多种 PIK3CA/AKT1/PTEN 改变的局部晚期或转移性乳腺癌的治疗。 此前（2023年11月16日）该药已获得美国FDA批准上市，与氟维司群（Fulvestrant）联合用于成人HR阳性、HER2阴性的转移性/局部晚期乳腺癌的治疗。 （十三）吡洛西利片 药品名称：吡洛西利片（Bireociclib，商品名：轩悦宁）。 研发公司：轩竹生物。 作用靶点：CDK4/6。 适应症：HR阳性、HER2阴性的晚期或转移性乳腺癌。 药品详情 吡洛西利片（Bireociclib，商品名：轩悦宁）是一款新型的CDK4/6选择性抑制剂，同时也是轩竹生物首个获批上市的抗肿瘤创新药。 2025年5月15日，该药的上市申请获国家药品监督管理局（NMPA）批准，用于成人HR阳性、HER2阴性的晚期或转移性乳腺癌的治疗。 该药本次获批主要基于一项BRIGHT-2临床研究（NCT05077449）的惊艳数据，结果显示：意向治疗（ITT）人群中，BF组ORR为39.7%，显著高于F组的13.9%。此外，BF组中位PFS为12.94个月，显著长于F组的7.29个月。 （十四）枸橼酸伏维西利胶囊 药品名称：枸橼酸伏维西利胶囊（复妥宁®）。 研发公司：复星医药控股子公司锦州奥鸿药业。 作用靶点：CDK4/6。 适应症：HR阳性、HER2阴性乳腺癌。 药品详情 枸橼酸伏维西利胶囊是一款创新型小分子 CDK4/6 抑制剂，通过抑制细胞周期进程，阻断细胞从 G1 期向 S 期过渡，从而有效减缓癌细胞的增殖速度，还可诱导肿瘤细胞凋亡，达到控制肿瘤发展的目的。 2025 年 5 月 29 日，获得国家药监局批准上市，用于成人既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子 2（HER2）阴性的复发或转移性乳腺癌的治疗。 （十五）盐酸来罗西利片 药品名称：盐酸来罗西利片（GB491，Lerociclib）。 研发公司：嘉和生物。 作用靶点：CDK4、CDK6。 适应症：HR+/HER2-的局部晚期或转移性乳腺癌。 药品详情 盐酸来罗西利片（GB491，Lerociclib）是一款高选择性口服型CDK4/6抑制剂，对CDK4和CDK6具有高度选择性和强效性，但对CDK9仅具有中度抑制作用。 2024年3月13日，中国国家药品监督管理局（NMPA）已正式受理盐酸来罗西利片的新药上市许可申请，与来曲唑联合，用于既往未经过系统性抗肿瘤治疗的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（HR+/HER2-）晚期乳腺癌的治疗。 LEONARDA-1 III期临床研究显示：盐酸来罗西利片（Lerociclib）组的中位无进展生存期（PFS）为11个月，而安慰剂组仅为5.5个月。 （十六）伊那利塞片 药品名称：伊那利塞片（Inavolisib，Itovebi，GDC-0077）。 研发公司：罗氏公司。 作用靶点：PI3Kα。 适应症：PIK3CA突变、HR阳性、HER2阴性乳腺癌。 药品详情 伊那利塞片是一款高选择性PI3Kα抑制剂，是中国首个获批的第三代高选择性PI3Kα抑制剂，同时也是首个获得中美双重突破性疗法认证的HR+乳腺癌治疗产品。2025年3月11日，该药的上市申请获中国国家药品监督管理局（NMPA）批准，与哌柏西利+氟维司群联合，用于内分泌治疗耐药（包括在辅助内分泌治疗期间或之后出现复发）、PIK3CA突变、HR（激素受体）阳性、HER2（人表皮生长因子受体2）阴性的局部晚期或转移性乳腺癌成人患者的治疗。 伊那利塞片本次获批，主要基于一项3期INAVO120临床研究（NCT04191499）数据。结果显示：Inavolisib（伊那利塞片）组的客观缓解率（ORR）高达58.4%，而安慰剂组仅为25.0%，伊那利塞片将客观缓解率足足提高了33.4个百分点。此外，Inavolisib将患者的中位无进展生存期（PFS）提高近一倍，分别为15.0个月（Inavolisib组） vs 7.3个月（安慰剂组）。 （十七）菲诺利单抗注射液 药品名称：菲诺利单抗注射液（Finotonlimab，SCT-I10A）。 研发公司：神州细胞。 作用靶点：PD-1。 适应症：肝细胞癌。 药品详情 菲诺利单抗注射液（Finotonlimab，SCT-I10A）是神州细胞自主研发的一款重组人源化抗PD-1 IgG4型单克隆抗体注射液。 2025年2月28日，菲诺利单抗注射液（SCT-I10A）与贝伐珠单抗注射液（SCT510）联合疗法，获中国国家药品监督管理局（NMPA）批准，用于既往未接受过系统治疗的不可切除或转移性肝细胞癌治疗。 （十八）苹果酸法米替尼胶囊 药品名称：苹果酸法米替尼胶囊。 研发公司：恒瑞医药。 适应症：晚期胃癌、转移性结直肠癌。 药品详情 苹果酸法米替尼胶囊是一种新型小分子多靶点酪氨酸激酶抑制剂，在多种实体瘤治疗中展现出潜力。目前已在国内获批的适应症包括晚期胃癌（三线治疗）、转移性结直肠癌（三线治疗）等，用于既往接受过标准化疗后进展或复发的患者。 （十九）注射用泽尼达妥单抗 药品名称：泽尼达妥单抗（Zanidatamab，ZW 25）。 研发公司：百济神州。 作用靶点：HER2。 适应症：胆道癌。 药品详情 泽尼达妥单抗（Zanidatamab）是一款针对HER2的双特异性抗体。2025年5月29日，注射用泽尼达妥单抗的上市申请获得中国NMPA批准，用于既往接受过全身治疗的HER2高表达（IHC3+）的不可切除局部晚期或转移性胆道癌的治疗。 本次获批主要基于一项2b期HERIZON-BTC-01（NCT04466891）临床研究的突破性数据，结果显示：在队列1（n=80）中，独立中央审查（ICR）评估的客观缓解率（ORR）为41.3%，中位缓解持续时间（DOR）长达12.9个月。 （二十）安罗替尼 药品名称：安罗替尼（福可维®）。 研发公司：正大天晴。 适应症：肾细胞癌。 药品详情 安罗替尼是我国自主研发的一种新型小分子多靶点酪氨酸激酶抑制剂（TKI），具有抗血管生成和抑制肿瘤生长的双重作用，在多种实体瘤治疗中应用广泛。2025年5月21日，中国国家药品监督管理局（NMPA）重磅宣布：安罗替尼与贝莫苏拜单抗联合疗法正式获批上市，用于晚期不可切除或转移性肾细胞癌（RCC）一线治疗。 该联合疗法的ETER100 III期临床研究（NCT04523272）数据，结果显示：联合治疗组展现出显著临床优势，中位无进展生存期（PFS）分别为18.96个月（联合治疗组） vs 9.76个月（舒尼替尼单药治疗组，HR=0.53，p<0.0001）。此外，联合治疗组的总缓解率高达71.6%，显著高于舒尼替尼单药治疗组的25.1%。 （二十一）厄达替尼片 药品名称：厄达替尼片（erdafitinib，Balversa）。 研发公司：强生。 作用靶点：FGFR3。 适应症：尿路上皮癌。 药品详情 厄达替尼片是一种全成纤维细胞生长因子受体(FGFR)抑制剂，具备显著的抗肿瘤活性。主要通过抑制FGFR的活性，切断肿瘤细胞的生长信号传导路径，进而对抗恶性肿瘤。 2025年1月13日，厄达替尼片的上市申请获中国国家药品监督管理局（NMPA）批准，用于携带易感型FGFR3基因突变、既往接受至少一线含抗PD-1或抗PD-L1期间或之后，病情进展且手术不可切除的局部晚期或转移性尿路上皮癌（UC）成人患者的治疗。 此前该药曾先后两次获美国FDA批准，用于成人在接受铂基化疗后，病情仍持续进展的局部晚期或转移性膀胱癌（2019年4月）、成人易感FGFR3/2变异，且在含铂化疗后病情出现进展的局部晚期或转移性尿路上皮癌（2024年1月）。 厄达替尼在中国的顺利获批，主要基于全球3期临床试验（THOR）的优异数据。结果显示：厄达替尼组的客观缓解率（ORR）为45.6%，显著高于化疗组的11.5%，其中9例患者（占比6.6%）达到完全缓解（CR）；在生存获益方面，厄达替尼组的中位无进展生存期（PFS）为5.6个月，长于化疗组的2.7个月，中位总生存期（OS）则为12.1个月，显著优于化疗组的7.8个月。 （二十二）塞纳帕利胶囊 药品名称：塞纳帕利（Senaparib）。 研发公司：英派药业。 作用靶点：PARP1/2。 适应症：上皮性卵巢癌、输卵管癌、原发性腹膜癌。 药品详情 塞纳帕利（Senaparib）是由英派药业自主研发的一款新型、高效的PARP1/2抑制剂，具有独特的分子结构，使其具备体外和体内高活性，以及高靶向选择性和广泛的安全窗口。 2025年1月16日，该药的上市申请获得NMPA批准上市，用于成人晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌在一线含铂化疗达到完全缓解或部分缓解后的维持治疗。 （二十三）氘恩扎鲁胺软胶囊 药品名称：氘恩扎鲁胺软胶囊（海纳安®）。 研发公司：海创药业。 适应症：转移性去势抵抗性前列腺癌。 药品详情 氘恩扎鲁胺软胶囊是我国自主研发的 1 类抗癌新药，同时也是第二代雄激素受体（AR）抑制剂恩扎卢胺的氘代药物，可竞争性抑制雄激素与其受体的结合，并可抑制雄激素受体的核转运和雄激素受体与 DNA 的相互作用，从而发挥抗癌作用。 2025 年 5 月末，氘恩扎鲁胺软胶囊获得国家药监局批准上市，6 月 20 日开出全国首张处方用于成人接受醋酸阿比特龙及化疗后出现疾病进展，且既往未接受新型雄激素受体抑制剂的转移性去势抵抗性前列腺癌（mCRPC）的治疗。 二、小编寄语 一种新药从开始申请，到最终应用于患者平均需要5年左右的时间；如果再算上纳入医保目录的时间，则需6～8年。值得欣慰的是，近年我国推出了多种抗癌救命药的改革方案，大大加速了国内抗癌新药的上市速度！小编也希望随着越来越多的抗癌新药获批并纳入医保范畴，能惠及更多的癌症患者！ 三、参考资料 [1]Lesokhin A M,et al.Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results[J]. Nature medicine, 2023, 29(9): 2259-2267. https://www.nature.com/articles/s41591-023-02528-9 [2]Passaro A,et al.Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study[J]. Annals of Oncology, 2024, 35(1): 77-90. https://www.annalsofoncology.org/article/S0923-7534(23)04281-3/fulltext [3]Wang J,et al.Bireociclib plus fulvestrant for HR+/HER2-advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis[J]. Nature Communications, 2025, 16(1): 3350. https://www.nature.com/articles/s41467-025-58647-z [4]Turner N C,et al.Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer[J]. New England Journal of Medicine, 2024, 391(17): 1584-1596. https://www.nejm.org/doi/full/10.1056/NEJMoa2404625 [5]https://www.urotoday.com/conference-highlights/esmo-2024/esmo-2024-kidney-cancer/154845-esmo-2024-anlotinib-combined-with-anti-pd-l1-antibody-benmelstobart-tqb2450-versus-sunitinib-in-first-line-treatment-of-advanced-renal-cell-carcinoma-rcc-a-randomized-open-label-phase-iii-study-eter100.html [6]Loriot Y,et al.Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma[J]. New England Journal of Medicine, 2023, 389(21): 1961-1971. https://www.nejm.org/doi/full/10.1056/NEJMoa2308849 本文为全球肿瘤医生网原创，未经授权严禁转载

In May 2025, the global pharmaceutical landscape witnessed a wave of innovation. From treating rare diseases such as KRAS‑mutant low‑grade serous ovarian cancer, pheochromocytoma, and paraganglioma to addressing widespread public health conditions like chronic obstructive pulmonary disease (COPD), postoperative pain, and influenza A virus infection, this series of drug approvals not only highlights the tireless efforts of medical researchers to overcome challenging diseases, but also reflects pharmaceutical companies’ ongoing commitment to advancing personalized and precision medicine. Notably, many of this month’s approved drugs are based on cutting‑edge biotechnologies and molecularly targeted therapies, offering new hope for patients with resistant or hard‑to‑treat conditions. 1. Avutometinib/Defactinib Avutometinib/Defactinib (AVMAPKI FAKZYNJA CO-PACK), developed by Verastem, is a combination of small-molecule drugs approved in the United States on May 8, 2025 for the treatment of KRAS‑mutant low‑grade serous ovarian cancer. Avutometinib is a RAF/MEK inhibitor that blocks the RAS‑RAF‑MEK‑ERK signaling pathway. It selectively inhibits MEK kinase activity, preventing downstream ERK activation and suppressing tumor cell proliferation and survival—a critical action in tumors harboring KRAS mutations that drive pathway hyperactivation. Defactinib is a focal adhesion kinase (FAK) inhibitor that disrupts tumor–stroma interactions, thereby reducing cancer cell migration, invasion, and metastatic potential. FAK is essential for cytoskeletal remodeling, adhesion, and motility; its overexpression is associated with numerous cancers. The combination yields synergistic effects: juntos they inhibit cell proliferation and prevent metastasis, offering a comprehensive therapeutic option for KRAS-mutant low-grade serous ovarian cancer. Clinical data demonstrate significant tumor growth inhibition and extended progression-free survival, improved patient quality of life, and a favorable safety and drug interaction profile. Verastem employed advanced formulation and pharmacokinetic design to ensure stability and bioavailability, showing comparable or superior efficacy compared with single agents. Post-approval, the company plans further pharmacovigilance, Phase IV trials to optimize dosing, expand indications, and evaluate long-term outcomes. Among current targeted therapies, several RAF/MEK and FAK inhibitors exist—Amgen’s Lumakras (sotorasib) and Mirati’s Adagrasib target KRAS G12C mutation directly—yet are mutation-specific. In contrast, Avutometinib/Defactinib offers broad-spectrum pathway inhibition, addressing complex KRAS-mutant cases. AstraZeneca’s Selumetinib (a MEK inhibitor) is another competitor, used in certain neurofibromatosis subtypes. 2. Velaglucerase Beta Velaglucerase beta (CAN‑103), developed by CANbridge Life Sciences, received approval in China on May 13, 2025 for the treatment of Gaucher disease types I and III. It is a humanized recombinant β‑glucocerebrosidase enzyme replacement therapy. Gaucher disease, caused by GBA gene mutations, results in deficient glucocerebrosidase activity, leading to intracellular lipid accumulation—especially in macrophages (so-called Gaucher cells)—and manifestations such as hepatosplenomegaly, bone disease, and systemic involvement. Velaglucerase beta provides functional enzyme to degrade stored glucocerebroside into glucose and ceramide, preventing lipid accumulation, restoring metabolic balance, and improving clinical outcomes. This enzyme demonstrates high stability and bioavailability, rapidly distributing to target tissues post-infusion and sustaining therapeutic effect. Clinical trials confirmed it significantly reduced liver and spleen volume, alleviated bone pain, increased hemoglobin, improved platelet counts, and enhanced quality of life—without serious adverse events. CANbridge utilized advanced bioprocessing and pharmacokinetic optimization to achieve equivalent or superior efficacy compared to existing enzyme replacement therapies. Following market approval, CANbridge will continue pharmacovigilance and Phase IV studies to expand indications and assess long-term efficacy. Existing Gaucher enzyme therapies include Sanofi’s Cerezyme and Pfizer’s Vpriv, both delivering exogenous enzyme effective for symptom improvement but subject to immune reaction-related variability. Velaglucerase beta, as a new humanized recombinant enzyme, offers improved affinity, lower immunogenicity, and high purity and stability—making it a favorable alternative in enzyme replacement therapy. 3. Anrikefon Anrikefon (HSK-21542), developed by Haisco Pharmaceutical Co., Ltd., was approved in China on May 13, 2025, for the treatment of postoperative pain. Anrikefon is a selective κ-opioid receptor agonist that exerts analgesic effects primarily by specifically binding to and activating κ-opioid receptors in the central and peripheral nervous systems. Compared to traditional μ-opioid receptor agonists, κ-opioid receptor agonists offer lower risks of addiction and respiratory depression while effectively relieving pain. By activating downstream signaling pathways through κ-receptor binding, Anrikefon suppresses nociceptive neuron activity and reduces the transmission of pain signals. Additionally, κ-opioid receptors play a role in emotional and stress regulation, making Anrikefon not only effective in relieving acute pain but also beneficial in improving mood and alleviating anxiety and depressive symptoms. Studies have shown that Anrikefon has high affinity and selectivity in vivo, delivering significant analgesic effects at lower doses and avoiding common side effects of traditional opioids, such as constipation, nausea, and vomiting. This unique mechanism of action positions Anrikefon as a highly promising novel analgesic. Clinical data demonstrate that Anrikefon provides excellent postoperative pain relief, significantly lowering pain scores and reducing the need for additional analgesics without causing severe adverse events or drug interactions. Currently, the postoperative pain management market includes widely used analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) and traditional opioids like morphine and oxycodone. While these drugs are effective in pain relief, they often come with adverse effects such as addiction, respiratory depression, and gastrointestinal disturbances. In contrast, Anrikefon, as a selective κ-opioid receptor agonist, provides superior safety and tolerability, reducing the risk of adverse effects while maintaining effective analgesia. Other competing products include Pfizer’s Remoxy (an extended-release opioid) and Egalet’s Arymo ER (an abuse-deterrent formulation of morphine), both designed to minimize misuse and side effects through enhanced drug delivery technologies. 4. Birociclib Birociclib, developed by Xuanzhu Pharmaceutical Technology Co., Ltd., was approved in China on May 13, 2025, for the treatment of HR-positive/HER2-negative breast cancer. Birociclib is a selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. It works by specifically inhibiting the CDK4/6–cyclin D complex, thereby preventing phosphorylation of the retinoblastoma (Rb) protein. When Rb is unphosphorylated, it halts cell cycle progression from the G1 to S phase, effectively suppressing tumor cell proliferation. In HR-positive/HER2-negative breast cancer, the estrogen receptor (ER) signaling pathway is frequently activated, leading to increased cyclin D expression and promoting Rb phosphorylation via CDK4/6. Birociclib blocks this pathway, thereby halting tumor cell growth and division. Moreover, CDK4/6 inhibitors have also been shown to enhance immune system recognition and elimination of tumor cells, potentially producing synergistic effects when used with immunotherapies. Studies demonstrate that Birociclib has high selectivity and affinity, achieving potent antitumor effects at lower doses with minimal impact on normal tissues. Clinical trial results show that Birociclib significantly prolongs progression-free survival (PFS) and increases objective response rates (ORR), improving overall clinical outcomes without serious adverse events or notable drug interactions. The HR-positive/HER2-negative breast cancer treatment landscape already includes several widely used CDK4/6 inhibitors such as Pfizer’s Ibrance, Novartis’ Kisqali, and Eli Lilly’s Verzenio. These agents block tumor cell proliferation by targeting CDK4/6 and have proven effective in extending PFS and improving quality of life. However, variations in side effect profiles and tolerability among patients can limit their use. In comparison, Birociclib offers higher selectivity and a more favorable safety profile, providing a safer and more effective treatment option for patients. 5. Telisotuzumab Vedotin Telisotuzumab vedotin (ABBV-399, ABT-399), developed by AbbVie with support from Pierre Fabre SA, received its first approval in the United States on May 14, 2025, for the treatment of c-Met–positive non-squamous non-small cell lung cancer (NSCLC). Telisotuzumab vedotin is an antibody-drug conjugate (ADC) that exerts potent and selective anti-tumor activity by specifically binding to c-Met receptors on the surface of tumor cells and delivering the cytotoxic payload vedotin directly into the cancer cells. The antibody portion of the ADC is a humanized monoclonal antibody that selectively targets c-Met, a receptor that is overexpressed in various types of cancer, particularly in c-Met–positive non-squamous NSCLC. Upon binding to c-Met, the ADC is internalized into the tumor cell, where it releases the cytotoxin monomethyl auristatin E (MMAE), a microtubule inhibitor. MMAE disrupts microtubule polymerization, resulting in cell cycle arrest and apoptosis. Thanks to this targeted delivery mechanism, Telisotuzumab vedotin can efficiently kill tumor cells while sparing normal tissues, enhancing efficacy and minimizing systemic toxicity. Studies have shown that this targeted system improves antitumor activity and reduces adverse effects, offering a safer and more effective treatment option. Clinical results demonstrated that Telisotuzumab vedotin significantly prolonged progression-free survival (PFS) and improved objective response rates (ORR), with no serious adverse events or significant drug interactions observed. Currently, several targeted therapies and immune checkpoint inhibitors are widely used in the treatment of c-Met–positive non-squamous NSCLC, such as Merck’s Keytruda and Roche’s Tecentriq. However, these treatments primarily rely on stimulating the immune system to attack tumors and may have limited efficacy in tumors driven by specific mutations or overexpression, such as c-Met–positive NSCLC. In contrast, Telisotuzumab vedotin, as a novel ADC, offers precise and potent targeting of c-Met, presenting a new and effective therapeutic option. Other competing products include Capmatinib and Crizotinib, both of which are small-molecule c-Met inhibitors. However, these agents are often associated with higher toxicity and resistance issues, making Telisotuzumab vedotin a promising alternative. 6. Boryung Flu Vaccine V Boryung Flu Vaccine V (보령플루백신V주), developed by Boryung Biopharma, is a vaccine designed to prevent influenza A and B virus infections. It was first approved in South Korea on May 19, 2025, for the prevention of influenza A and B. Boryung Flu Vaccine V is an inactivated influenza vaccine prepared using killed strains of influenza A and B viruses. It works by introducing inactivated viral antigens into the body to stimulate the immune system to generate specific antibodies. The inactivated virus particles retain key surface antigens—hemagglutinin (HA) and neuraminidase (NA)—which are recognized and remembered by the immune system. Following vaccination, antigen-presenting cells capture and present these antigens to helper T cells and B cells, activating an adaptive immune response. B cells produce large quantities of antibodies, especially neutralizing antibodies that bind to the HA proteins on the virus surface, thereby blocking viral entry into host cells and preventing infection. In addition, memory B and T cells are generated, providing long-term immunity and enabling a rapid immune response upon re-exposure to the same or similar influenza viruses. Given the annual antigenic changes in circulating influenza strains, the formulation of Boryung Flu Vaccine V is updated annually based on recommendations from the World Health Organization (WHO) to ensure optimal protective efficacy. Currently, several influenza vaccines are widely available on the market, including Sanofi Pasteur’s Fluzone, GSK’s Fluarix, and AstraZeneca’s FluMist. These vaccines come in various forms, such as inactivated vaccines, live attenuated vaccines, and recombinant subunit vaccines. Each type has unique advantages and target populations. For instance, inactivated vaccines are suitable for most individuals, including the elderly and children; live attenuated vaccines are typically administered intranasally and are suitable for healthy individuals in specific age groups; recombinant vaccines are preferred for those with egg allergies or contraindications to traditional formulations. Compared to existing options, Boryung Flu Vaccine V, as a new-generation inactivated vaccine, demonstrates high immunogenicity and a strong safety profile, offering effective protection for a broad population. 7. Onradivir Onradivir (ZSP-1273), developed by Zhongsheng Pharmaceutical, was first approved in China on May 20, 2025, for the treatment of influenza A virus infections. Onradivir is a small-molecule antiviral agent specifically designed to inhibit RNA-dependent RNA polymerase (RdRp) of the influenza A virus, thereby blocking the viral replication process. RdRp is essential for synthesizing the viral genomic RNA, a key step in the propagation and transmission of the virus. Onradivir binds to RdRp, disrupting its normal function and preventing the synthesis of viral RNA, thus inhibiting replication within host cells. Studies show that Onradivir exhibits high selectivity and affinity, achieving potent antiviral effects at low concentrations while minimizing cytotoxicity to host cells. Moreover, because its mechanism of action targets a central step in the viral life cycle, Onradivir has a lower tendency to induce resistance mutations, giving it a potential advantage in long-term treatment. Compared to existing anti-influenza drugs such as Oseltamivir, which primarily inhibit viral neuraminidase, Onradivir directly targets a critical enzyme in viral replication, offering a more precise and effective therapeutic strategy. Clinical studies have demonstrated that Onradivir significantly shortens the duration of illness, reduces viral load, and improves clinical symptoms, accelerating patient recovery without causing severe adverse events or drug interactions. Zhongsheng Pharmaceutical has also utilized advanced drug design and manufacturing technologies to ensure high stability and bioavailability, with detailed pharmacokinetic studies indicating efficacy comparable to or better than existing influenza therapies. Post-marketing, the company continues to monitor the drug’s performance and plans to conduct Phase IV clinical trials to explore additional indications and long-term benefits. Currently, several antiviral drugs are available for treating influenza A virus infections, such as Tamiflu (Oseltamivir) by Roche and Relenza by GSK. These drugs function by inhibiting neuraminidase, preventing the release of newly formed viral particles from infected cells and slowing viral spread. However, the emergence of resistant viral strains has made the development of novel therapeutic strategies increasingly important. In this context, Onradivir, as a new RdRp inhibitor, provides a fundamentally different and more direct approach to suppressing viral replication. Other alternatives, such as Laninamivir by Merck, are long-acting neuraminidase inhibitors administered via a single inhalation dose, but their availability and use remain limited in certain regions. 8. Glecirasib Glecirasib Citrate, developed by Jacobio Pharmaceuticals Group Co., Ltd., was first approved in China on May 20, 2025, for the treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation. Glecirasib is a selective small-molecule inhibitor that targets the KRAS G12C mutation, a known driver of oncogenesis in various cancers. It works by covalently binding to the cysteine residue at the G12C mutation site of the KRAS protein, thereby locking it in its inactive GDP-bound state and preventing downstream signaling activation. Under normal physiological conditions, KRAS functions as a molecular switch that toggles between an active (GTP-bound) and inactive (GDP-bound) state to regulate cell proliferation, differentiation, and survival. However, in tumors harboring the KRAS G12C mutation, the protein remains constitutively active, leading to continuous signal transduction and uncontrolled cell growth. Glecirasib’s covalent binding to the mutant site inhibits the RAS-RAF-MEK-ERK signaling cascade, effectively suppressing tumor cell growth and metastasis. Preclinical and clinical data demonstrate that Glecirasib offers high selectivity and potency, exerting strong antitumor effects at low doses while minimizing toxicity to normal tissues. Its unique mechanism of action also reduces the likelihood of resistance mutations, suggesting potential advantages for long-term therapy. Currently, other approved therapies for KRAS G12C-mutant NSCLC include Lumakras (Sotorasib) by Amgen and Adagrasib by Mirati Therapeutics. These drugs also inhibit KRAS G12C and have been shown to significantly extend progression-free survival and improve quality of life. However, some patients develop resistance or are unable to tolerate their side effects. In contrast, Glecirasib, as a next-generation KRAS G12C inhibitor, offers greater selectivity and a more favorable safety profile, providing a promising alternative for patients with this difficult-to-treat mutation. Other related therapeutic agents include Selumetinib by AstraZeneca, a MEK inhibitor used in the treatment of certain types of neurofibromatosis, which acts downstream of KRAS in the same signaling pathway. 9. Jaktinib Hydrochloride Jaktinib Hydrochloride, developed by Zelgen Biopharma Co., Ltd., was first approved in China on May 27, 2025, for the treatment of adult patients with intermediate- or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF). It is indicated for the reduction of disease-related splenomegaly and symptoms. Jaktinib is the first domestically developed JAK inhibitor approved in China for myelofibrosis. It is a novel drug that inhibits JAK1, JAK2, JAK3, and TYK2, thereby blocking the JAK-STAT signaling pathway, which plays a central role in the pathogenesis of myelofibrosis. Additionally, it targets ACVR1, a receptor involved in iron metabolism, helping to correct iron dysregulation and improve anemia. In a Phase III clinical trial, 72.3% of patients achieved a ≥35% reduction in spleen volume (SVR35) at 24 weeks, significantly outperforming hydroxyurea (50%). Among patients who were refractory or intolerant to ruxolitinib, SVR35 was 43.2% in a Phase IIB trial and 32.4% in a Phase II trial. Jaktinib also showed notable efficacy in improving anemia and relieving symptoms (with 62% of patients experiencing a ≥50% reduction in total symptom score). Importantly, no Grade 3 or higher hematologic toxicities were reported, and gastrointestinal adverse events occurred at significantly lower rates than with similar agents. 10. Fovinaciclib Fovinaciclib Citrate (FCN-437), developed by Jinzhou Ahon Pharmaceutical, was first approved in China on May 27, 2025, for the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer. Fovinaciclib is a selective CDK4/6 inhibitor that works by inhibiting the formation of CDK4/6–cyclin D complexes, thereby preventing the phosphorylation of the retinoblastoma (Rb) protein. The unphosphorylated Rb protein halts the cell cycle at the G1 phase, blocking progression into the S phase and inhibiting tumor cell proliferation. In HR+/HER2− breast cancer, the estrogen receptor (ER) signaling pathway is often activated, leading to upregulation of cyclin D and CDK4/6 activity, which promotes Rb phosphorylation and cell cycle progression. Fovinaciclib interrupts this process, thereby suppressing tumor growth and cell division. CDK4/6 inhibitors may also enhance immune recognition and cytotoxicity toward tumor cells, potentially synergizing with other immunotherapies. 11. Luvometinib Luvometinib (FCN-159), developed by Fochon Pharmaceuticals, was first approved in China on May 27, 2025. As a highly selective MEK1/2 inhibitor, Luvometinib was approved for the treatment of adult patients with Langerhans cell histiocytosis (LCH) or histiocytic tumors, as well as for children and adolescents aged 2 years and older with inoperable, symptomatic plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1). Luvometinib works by precisely inhibiting MEK1/2, key proteins in the MAPK signaling pathway, thereby blocking aberrant pathway activation. This inhibition suppresses tumor cell proliferation and induces apoptosis, delivering rapid clinical efficacy and a manageable safety profile. Compared to existing treatment options, Luvometinib offers a faster onset of action, providing new possibilities for clinical management. In addition to the approved indications, Luvometinib is also being investigated in other clinical trials, including a Phase III trial for NF1 in adults, and Phase II trials for conditions such as low-grade glioma and extracranial arteriovenous malformations. Several of these indications have been granted Breakthrough Therapy designation. 12. Trastuzumab Rezetecan Trastuzumab Rezetecan (SHR-A1811), developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd., is an antibody-drug conjugate (ADC) that was first approved in China on May 27, 2025, for the treatment of adult patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This approval was based on the results of the multicenter Phase 1/2 clinical study HORIZON-Lung, which demonstrated a remarkable objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months. The incidence of interstitial lung disease (ILD) was only 8.5%, which is significantly lower than similar ADCs, offering a new "high-efficacy, low-toxicity" option for Chinese patients with HER2-mutant NSCLC. Trastuzumab Rezetecan consists of the trastuzumab backbone (SHR-1805), a GGFG linker, and a novel payload Rezivertinib, and incorporates three key proprietary innovations: ·Rezivertinib exhibits enhanced membrane permeability and cytotoxicity, increasing the bystander killing effect. ·It demonstrates a lower payload release rate in plasma compared to similar agents, enhancing safety. ·The DAR (drug-to-antibody ratio) of 6 is optimized to balance efficacy and toxicity. These features contribute to its superior antitumor activity and lower risk of adverse events. In the HORIZON-Lung trial, consistent efficacy and tolerability were observed regardless of brain metastasis status or prior TKI treatment. Subgroup analysis showed an ORR of 87.5% in patients with brain metastases and 81.8% in those previously treated with TKIs. Additionally, the 12-month overall survival rate was 88.2%, with a treatment discontinuation rate of only 2.1% due to adverse events and an ILD incidence of 8.5%. These results represent a significant milestone in HER2-mutant lung cancer treatment in China and set a new benchmark in global ADC development. 13. Human Papillomavirus Recombinant Vaccine (Cecolin 9) Cecolin 9 (Human papillomavirus recombinant vaccine nonavalent), developed by Innovax Biotech, was first approved in China on May 27, 2025. It covers seven high-risk HPV types (16, 18, 31, 33, 45, 52, and 58) and two low-risk types (6 and 11) and is indicated for females aged 9 to 45 years. This approval marks China as the second country in the world, after the United States, to independently supply a nonavalent HPV vaccine, enhancing vaccine accessibility and public health protection for women. 14. Albipagrastim Alfa Albipagrastim alfa (8MW0511, GW-003), developed by Mabwell (Shanghai) Bioscience Co., Ltd., was first approved in China on May 27, 2025. It is Mabwell’s first Class 1 innovative drug to be approved and the first granulocyte colony-stimulating factor (G-CSF) product in China developed using albumin-fusion long-acting technology. It is indicated for reducing the risk of infection in adult patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy associated with febrile neutropenia (FN). Albipagrastim alfa fuses a highly active engineered G-CSF with human serum albumin (HSA), significantly prolonging its half-life and thus reducing dosing frequency and improving patient compliance. Compared to traditional chemically modified long-acting G-CSFs, it is produced via a Pichia pastoris expression system, offering a simpler manufacturing process and better product homogeneity. The use of natural human protein as a carrier further enhances safety. In a Phase III clinical trial involving 496 breast cancer patients, 8MW0511 outperformed the positive control drug Pegleukin in reducing the incidence of Grade 4 neutropenia and febrile neutropenia, with a favorable safety and tolerability profile. The approved indication targets chemotherapy-induced neutropenia, one of the most common hematologic toxicities in clinical oncology, especially with regimens containing paclitaxel, doxorubicin, or cyclophosphamide. According to statistics, the number of new global cancer cases is projected to reach 5.03 million in 2025, with a sharp rise in chemotherapy patients by 2040, indicating a promising market outlook for neutropenia prevention and treatment drugs. 15. Deuterated Enzalutamide Deuterated Enzalutamide (HC-1119), developed by Hinova Pharmaceuticals, was first approved in China on May 27, 2025, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have disease progression after treatment with abiraterone acetate and chemotherapy, and have not previously received next-generation androgen receptor inhibitors. Deuterated enzalutamide is a second-generation androgen receptor (AR) inhibitor. Results from a Phase III clinical trial demonstrated that it significantly prolonged progression-free survival and reduced the risk of disease progression or death by 42% compared to the control group. Moreover, compared to other novel endocrine therapies, deuterated enzalutamide exhibited a favorable safety profile, with a lower incidence of central nervous system adverse events, reduced risk of rash-related side effects, and fewer common complications in elderly patients. 16. Lerociclib Lerociclib, jointly developed by Genor Biopharma and G1 Therapeutics (U.S.), was first approved in China on May 27, 2025. Lerociclib is a novel, potent, and highly selective oral CDK4/6 inhibitor designed for use in combination with endocrine therapy for the treatment of advanced breast cancer. The drug features a unique molecular structure and optimized pharmacokinetics, allowing continuous oral dosing without treatment breaks, thereby ensuring sustained target inhibition and robust antitumor activity. It also demonstrates a differentiated safety advantage. Clinical trials have shown that lerociclib delivers excellent efficacy in patients with endocrine-resistant and visceral metastatic advanced breast cancer, while also reducing common adverse events such as severe myelosuppression and diarrhea. It is indicated for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, to be used either in combination with aromatase inhibitors as initial endocrine therapy or with fulvestrant in patients whose disease has progressed following prior endocrine therapy. 17. Famitinib Malate Famitinib Malate (SHR-1020), developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd., was first approved in China on May 27, 2025, for the treatment of patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy and have not been previously treated with bevacizumab. Famitinib is a small-molecule tyrosine kinase inhibitor (TKI) that targets PDGFR-β, VEGFR, and c-Kit, among others. By competitively binding to the intracellular tyrosine kinase domains, famitinib inhibits their phosphorylation, thereby blocking downstream signaling pathways and inhibiting tumor angiogenesis. Camrelizumab, a humanized PD-1 monoclonal antibody also developed by Hengrui, can be used in combination with famitinib to restructure the tumor vasculature and immune microenvironment, resulting in synergistic anti-tumor effects. Based on results from a randomized, open-label, controlled, multicenter Phase II clinical trial, the combination of famitinib and camrelizumab significantly improved objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Among patients who had not previously received bevacizumab, the combination therapy achieved an ORR of 44.6% compared to 22.6% with camrelizumab monotherapy. The median PFS reached 6.4 months, and median OS extended to 20.2 months. In terms of safety, the combination therapy did not introduce any new adverse event profiles, confirming its tolerability. 18. Acoltremon Acoltremon (AR-15512, TRYPTYR), developed by Alcon, was first approved in the United States on May 28, 2025, for the treatment of signs and symptoms of dry eye disease (DED). It is the first approved TRPM8 receptor agonist for DED, introducing a novel mechanism of action by stimulating corneal sensory nerves to rapidly promote natural tear secretion. The approval was based on results from two randomized, double-blind, controlled clinical trials—COMET-2 and COMET-3—involving a total of 931 patients with dry eye disease. The results showed that Tryptyr demonstrated significant efficacy early in treatment. On Day 14, the percentage of patients with an increase of ≥10 mm in tear secretion score from baseline was 42.6% and 53.2% in the two trials, respectively, significantly higher than the placebo groups. The improvement in tear production was sustained through Day 90, demonstrating long-lasting effects. The most common adverse event reported was instillation site pain. Tryptyr will be available in single-dose vials, administered as one drop in each eye twice daily. Alcon plans to launch the product in the U.S. in Q3 2025, followed by expansion into other markets. This innovative therapy offers a new treatment option for millions of dry eye patients worldwide. 19. mNEXSPIKE mNEXSPIKE (mRNA-1283), developed by ModernaTX, Inc., is an mRNA-based COVID-19 vaccine that was approved on May 31, 2025, for the prevention of COVID-19 caused by SARS-CoV-2. The approval specifically applies to two population groups: ·Individuals aged 65 and older who have previously received any COVID-19 vaccine ·Individuals aged 12 to 64 who have at least one underlying medical condition placing them at high risk of serious outcomes from COVID-19 infection mNEXSPIKE utilizes messenger RNA (mRNA) technology. It delivers an mRNA sequence encoding the spike (S) protein of SARS-CoV-2 into human cells, prompting temporary intracellular production of the antigen, which triggers both humoral and cellular immune responses. The mRNA is encapsulated in lipid nanoparticles (LNPs) to ensure stability and efficient cellular uptake. Once inside the host cell cytoplasm, the mRNA is translated into the S protein, which is then presented on the cell surface or secreted, activating antigen-presenting cells (such as dendritic cells), and stimulating B cells to generate neutralizing antibodies, while also promoting the formation of memory T cells. This dual immune activation mechanism allows mNEXSPIKE to not only neutralize the original SARS-CoV-2 strain, but also to offer broad protection against multiple variants. Compared to inactivated or recombinant protein-based vaccines, mNEXSPIKE provides higher immunogenicity, greater flexibility in sequence design, and faster manufacturing response times, making it particularly suited to address the evolving virus landscape. mNEXSPIKE has also been optimized in terms of dosage and storage compared to its predecessor, Spikevax. It uses one-fifth the dose and features improved shelf-life across various temperatures, owing to a shorter and more stable mRNA strand that encodes only the receptor-binding domain (RBD) and N-terminal domain (NTD) of the spike protein.   The month of May 2025 marked the approval of several milestone therapies that not only expanded the landscape of existing treatment options but also laid the foundation for transformative shifts in future medical practices. 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