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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
China’s rise in cutting-edge pharmaceutical innovation received a major fillip with the USFDA approval of Zegfrovy (sunvozertinib) for non-small cell lung cancer (NSCLC). Developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd., it appears to be the first New Molecular Entity (NME) to be discovered, developed, and filed independently by a Chinese company for U.S. approval.
In recent years, China has made remarkable progress in novel drug development, with several NMEs gaining regulatory approvals in the U.S. and Europe. These include:
| Molecule | Chinese Developer | Global Partner(s) | Indication | Region Approved | Year |
| Zanubrutinib | BeiGene | Novartis | B-cell malignancies (BTK inhibitor) | U.S. FDA | 2019 |
| Fruquintinib | HUTCHMED | Takeda | Metastatic colorectal cancer | U.S. FDA | 2023 |
| Toripalimab | Junshi Biosciences | Coherus BioSciences | Nasopharyngeal carcinoma | U.S. FDA | 2023 |
| Tislelizumab (Tevimbra) | BeiGene | Novartis | Various cancers (PD-1 inhibitor) | EU | 2023 |
| Cilta-cel | Legend Biotech | Janssen (J&J) | Multiple myeloma (CAR-T therapy) | U.S. FDA | 2022 |
However, most of these molecules were either co-developed with global pharma majors or licensed for late-stage development and commercialization.
For decades, China and India have played central roles in global pharmaceutical supply. While India has dominated the generics space, contributing over 50% of global demand for finished dosage forms and often called “Pharmacy of the World,” China has led in active pharmaceutical ingredient (API) production. Yet, in the realm of new molecular entities and biopharmaceuticals, China has clearly pulled ahead with a growing list of global approvals. Until very recently, India had not seen a truly homegrown New Molecular Entity (NME) approved by the USFDA, either independently or through global partnerships. Enmetazobactam, discovered by Orchid Pharma in 2008 and out-licensed to Allecra Therapeutics (Germany), became India’s first USFDA-approved NME in 2024. It was approved in the fixed-dose combination Exblifep (cefepime + enmetazobactam) for complicated urinary tract infections (cUTI). Previously, Umbralisib, discovered by Rhizen (associated with Alembic) and licensed to TG Therapeutics, received USFDA approval in 2021. However, it was withdrawn subsequently due to safety concerns.
Another promising Indian-origin molecule is Saroglitazar by Zydus, which has received Fast Track Designation from the USFDA but is still under clinical evaluation for conditions including Non-Alcoholic Fatty Liver Disease (NAFLD) and other liver diseases.
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