YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 387 drug applications between 8 November 2025 and 14 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 56 drug names.
2025/11/08 – 2025/11/14
- New acceptances this week
- 387
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 83
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
387filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 202 |
| Generic | 79 |
| New drug | 64 |
| Import | 25 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 111 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 7 |
| Biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 3 | 2 | 69 |
| 2 | 奥氮平萨米多芬片 · No verified English name | 3 | 1 | 0 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | 二甲硅油乳剂 · No verified English name | 2 | 2 | 14 |
| 5 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Iguratimod Tablets | 2 | 2 | 23 |
| 8 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 9 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 10 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Takeda Development Center Americas Inc. | 8 | 3 | 0 |
| 2 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 7 | 3 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 3 | 0 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 7 | Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 9 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | AstraZeneca AB | 5 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/14Import · Class 2.2 | Mirikizumab注射液 · No verified English nameJXSL2500223 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Import · Class 2.2 | Mirikizumab注射液 · No verified English nameJXSL2500222 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Import · Class 1 | LY4268989胶囊 · No verified English nameJXHL2500353 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503967 | Jiangxi Yuan Sheng Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/11/14Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503966 | Jiangxi Yuan Sheng Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/11/14Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2503963 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/11/14Generic · Class 3 | Diprophylline InjectionCYHS2503961 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2025/11/14Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2503958 | Hainan Sai Li Ke Pharma Co., Ltd. romanized |
| 2025/11/14Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503955 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.4 | YFZ-003 · No verified English nameCXZL2500116 | Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.4 | YFZ-003 · No verified English nameCXZL2500115 | Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.4 | YFZ-003 · No verified English nameCXZL2500114 | Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.4 | YFZ-003 · No verified English nameCXZL2500113 | Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500969 | Shanghai Yu Guan Bio Technology Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500968 | Shanghai Yu Guan Bio Technology Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500967 | Shanghai Yu Guan Bio Technology Co., Ltd. romanized |
| 2025/11/14New drug · Class 1 | IBI343 · No verified English nameCXSL2500966 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2 | 玛舒拉沙韦干混悬剂 · No verified English nameCXHS2500136 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2; 2.4 | SQ-24071滴眼液 · No verified English nameCXHL2501261 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2; 2.4 | SQ-24071滴眼液 · No verified English nameCXHL2501260 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2; 2.4 | SQ-24071滴眼液 · No verified English nameCXHL2501259 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2; 2.4 | SQ-24071滴眼液 · No verified English nameCXHL2501258 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2025/11/14New drug · Class 1 | RTX-117片 · No verified English nameCXHL2501255 | Xi Li Technology (Shenzhen) Co., Ltd. romanized |
| 2025/11/14New drug · Class 1 | RTX-117片 · No verified English nameCXHL2501254 | Xi Li Technology (Shenzhen) Co., Ltd. romanized |
| 2025/11/14New drug · Class 2.2 | HKG-456 · No verified English nameCXHL2501253 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/14New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2501252 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/11/13Import · Class 2.2 | 多奈单抗注射液 · No verified English nameJXSL2500221 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500131 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500130 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500129 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
84 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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