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相关临床试验
229
3 进行中
药物批准
184
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
2
0.9%
已完成
216
94.3%
尚未招募
1
0.4%
招募中
3
1.3%
终止
Unknown
1.8%
撤回
NMPA
National Medical Products Administration
15
FDA
Food and Drug Administration
127
PHILIPPINES
Philippines FDA
NPRA
National Pharmaceutical Regulatory Agency
39
- India's Subject Expert Committee recommended waiving local Phase III and bioequivalence trials for generic lenacapavir PrEP from Dr. Reddy's and Emcure Pharmaceuticals. - The waiver applies only to the HIV prevention (PrEP) indication, not to treatment of multidrug-resistant HIV-1, which requires additional pharmacokinetic and ethnicity data. - Marketing authorization would be conditional on mandatory post-marketing Phase IV efficacy studies, with protocols due to CDSCO within three months. - Lenacapavir, a first-in-class long-acting capsid inhibitor, showed zero infections in PURPOSE 1 and a 96% incidence reduction in PURPOSE 2.
