YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 421 drug applications between 5 December 2025 and 11 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 67 drug names.
2025/12/05 – 2025/12/11
- New acceptances this week
- 421
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 130
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
421filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| New drug | 112 |
| Generic | 95 |
| Unspecified | 18 |
| Import re-registration | 13 |
| Import | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 87 |
| Therapeutic biologic | 56 |
| Biologic | 14 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 4 |
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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 5 | 3 | 52 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Norepinephrine Bitartrate Injection | 3 | 2 | 9 |
| 4 | Finerenone Tablets | 3 | 2 | 69 |
| 5 | Riociguat Tablets | 3 | 1 | 4 |
| 6 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 7 | Pregabalin Capsules | 3 | 1 | 12 |
| 8 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 9 | 多种微量元素注射液(IV) · No verified English name | 2 | 1 | 4 |
| 10 | 左羟丙哌嗪糖浆 · No verified English name | 2 | 1 | 0 |
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
256 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 6 | 0 |
| 3 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 7 | Bayer AG | 5 | 2 | 0 |
| 8 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 9 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 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
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/11Generic · Class 3 | Dexrazoxane for InjectionCYHS2504264 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/12/11Generic · Class 3 | Benzbromarone TabletsCYHS2504255 | Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/12/11Generic · Class 3 | Minoxidil LinimentCYHS2504247 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized |
| 2025/12/11Generic · Class 3 | Minoxidil LinimentCYHS2504246 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized |
| 2025/12/11Generic · Class 3 | 左氧氟沙星滴耳液 · No verified English nameCYHS2504245 | Yunnan Dai Yao Co., Ltd. romanized |
| 2025/12/11New drug · Class 1.1 | 葛石通脉颗粒 · No verified English nameCXZL2500127 | Zhongguo Zhong Yi Ke College Zhong Yi Lin Chuang Ji Chu Yi Xue Research Institute romanized |
| 2025/12/11New drug · Class 1.1 | 清胆止痒颗粒 · No verified English nameCXZL2500126 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2025/12/11New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500140 | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized |
| 2025/12/11New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500139 | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized |
| 2025/12/11New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2500138 | Hua Lan An Kang Bio Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | FS-8002注射液 · No verified English nameCXSL2501073 | Shanghai Pu Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2501072 | Shanghai Jun Sai Bio Co., Ltd. romanized; Shanghai Jun Sai Bio Pharma Co., Ltd. romanized |
| 2025/12/11New drug · Class 2.1; 2.3 | SHR-2524注射液 · No verified English nameCXSL2501071 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/11New drug · Class 2.1; 2.3 | SHR-2524注射液 · No verified English nameCXSL2501070 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | NS-136片 · No verified English nameCXHL2501382 | Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | NS-136片 · No verified English nameCXHL2501381 | Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | AN9025胶囊 · No verified English nameCXHL2501380 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GW5282片 · No verified English nameCXHL2501379 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | AN9025胶囊 · No verified English nameCXHL2501378 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GW5282片 · No verified English nameCXHL2501377 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GTA182片 · No verified English nameCXHL2501376 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GTA182片 · No verified English nameCXHL2501375 | Shanghai Pai Long Bio Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 2.2; 2.4 | YN018注射液 · No verified English nameCXHL2501374 | Shanghai Yan Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 2.1 | 注射用二氢卟吩e6三葡甲胺盐 · No verified English nameCXHL2501373 | Kang E (Shanghai) Medical Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 2.1 | 注射用二氢卟吩e6三葡甲胺盐 · No verified English nameCXHL2501372 | Kang E (Shanghai) Medical Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | 注射用Hemay5087 · No verified English nameCXHL2501371 | Tianjin He Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501369 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501368 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501367 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/11New drug · Class 1 | TCR1672缓释片 · No verified English nameCXHL2501366 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
123 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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