Drugs / TQ05105
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | familial myelofibrosis | 2024-07-13 | “2024年7月，TQ05105已在国内提交上市申请，用于治疗中高危骨髓纤维化（MF）。” cttq.com ↗ “去年7月已在中国递交治疗中高危骨髓纤维化的上市申请” cttq.com ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07608666 | Jul → Dec 2026 expected | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07708272 | Jul → Dec 2026 expected | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07293390 | Mar → Apr 2024 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06024915 | Sep 2023 → Jan 2024 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05982106 | Jul 2021 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04326348 | Jul 2020 → Jan 2022 | hemophagocytic syndrome | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04339400 | Nov 2018 → Mar 2023 | myeloproliferative neoplasm | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06245941 | May 2024 → Dec 2025 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded |
| Phase 1/2 | NCT06122831 | Dec 2023 → Dec 2026 expected | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04941404 | Jun 2022 → Jul 2023 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 22 trials | ||||||
| Phase 2 | NCT07551427 | Jun 2026 → Jun 2028 expected | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05020652 | Nov 2021 → Oct 2023 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT07480824 Comparator | Apr → Oct 2026 expected | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06598956 Comparator | Oct 2024 → Mar 2025 | myelofibrosis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-02-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory FIC新药获批！正大天晴JAK/ROCK抑制剂罗伐昔替尼开启骨髓纤维化一线治疗新范式 cttq.com ↗
2月28日，正大天晴1类创新药罗伐昔替尼片（安煦®，TQ05105）在国内获批上市，用于中危-2或高危的原发性骨髓纤维化（PMF）、真性红细胞增多症后骨髓纤维化（PPV-MF）或原发性血小板增多症后骨髓纤维化（PET-MF）成年患者的一线治疗。 |
| 2025-08-07 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴罗伐昔替尼片（JAK/ROCK抑制剂）纳入突破性治疗药物程序 cttq.com ↗
近日，正大天晴1类新药罗伐昔替尼片（Rovadicitinib，TQ05105）纳入突破性疗法，用于慢性移植物抗宿主病（cGVHD）的治疗。 |
| 2025-06-18 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 激素耐药aGVHD患者福音！罗伐昔替尼亮相EHA 2025，口头报告Ib期临床结果 cttq.com ↗
对于激素耐药的aGVHD患者，28天总体缓解率达84%，肠道缓解率高达80%，呈现出反应率高、起效迅速、持久缓解的特点。 |
| 2025-01-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴罗伐昔替尼在美获批临床 国内治疗骨纤维化适应症上市申请已获受理 cttq.com ↗
1月14日，正大天晴自主研发的一款具有全新化学结构的JAK/ROCK抑制剂罗伐昔替尼片（TQ05105）II期临床试验申请（IND）获得美国食品药品监督管理局（FDA）批准，拟用于治疗慢性移植物抗宿主病（cGVHD）。 |
| 2024-07-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴1类创新药罗伐昔替尼片（Rovadicitinib）上市申请获受理 cttq.com ↗
7月13日，国家药监局药品审评中心（CDE）官网公示，正大天晴1类新药罗伐昔替尼片（Rovadicitinib，TQ05105）上市申请已获得受理，用于治疗中高危骨髓纤维化（MF）。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-28 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | FIC新药获批！正大天晴JAK/ROCK抑制剂罗伐昔替尼开启骨髓纤维化一线治疗新范式 cttq.com ↗ |
| 2025-08-07 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴罗伐昔替尼片（JAK/ROCK抑制剂）纳入突破性治疗药物程序 cttq.com ↗ |
| 2025-06-18 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 激素耐药aGVHD患者福音！罗伐昔替尼亮相EHA 2025，口头报告Ib期临床结果 cttq.com ↗ |
| 2025-01-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴罗伐昔替尼在美获批临床 国内治疗骨纤维化适应症上市申请已获受理 cttq.com ↗ |
| 2024-07-15 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 正大天晴1类创新药罗伐昔替尼片（Rovadicitinib）上市申请获受理 cttq.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TQ05105 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07293390 ↗ |
| Known as | Rovadicitinib | “TQ05105 Tablets (Rovadicitinib Tablets)” NCT07551427 ↗ |
| Action | Inhibit | “TQ05105 is a JAK2 inhibitor.” NCT04326348 ↗ |
| Modality | Small molecule | “a class 1 new drug with a new chemical structure” NCT05982106 ↗ |
| Route | Oral | “TQ05105 tablet administered orally, twice daily in 28-day cycle after 3 days of first administration.” NCT04326348 ↗ |
| Target | JAK2 | “TQ05105 is a JAK2 inhibitor.” NCT04326348 ↗ |