YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 520 drug applications between 15 October 2025 and 21 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 63 drug names.
2025/10/15 – 2025/10/21
- New acceptances this week
- 520
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 119
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
520filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 288 |
| New drug | 97 |
| Generic | 86 |
| Unspecified | 22 |
| Import | 22 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 341 |
| TCM | 81 |
| Therapeutic biologic | 78 |
| Biologic | 15 |
| Prophylactic biologic | 4 |
| Unspecified | 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 5 | 5 | 51 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 4 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 5 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 6 | MOVICOL Ready To Take Sachet, Powder For Oral Solution | 2 | 2 | 16 |
| 7 | 呋喃妥因胶囊 · No verified English name | 2 | 1 | 4 |
| 8 | Digoxin Injection | 2 | 1 | 3 |
| 9 | Imipenem and Cilastatin Sodium for Injection | 2 | 1 | 6 |
| 10 | 注射用氨曲南/氯化钠注射液 · 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
266 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 64 | 47 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 11 | 2 | 0 |
| 3 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 5 | Terumo Corporation Kofu Factory | 8 | 1 | 0 |
| 6 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 7 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Sanofi-Aventis Recherche & Développement | 6 | 3 | 0 |
| 9 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 6 | 2 | 1 |
| 10 | Tong Hua Si Wei Pharma Co., Ltd. romanized | 5 | 5 | 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
154 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/21Import · Class 1 | 注射用PF-08046050 · No verified English nameJXSL2500207 | Seagen Inc. a wholly owned subsidiary of Pfizer; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2025/10/21Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2503753 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2025/10/21Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2503752 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2025/10/21Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503750 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/10/21Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503749 | Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/10/21Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2503744 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2025/10/21Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503741 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2025/10/21Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2503740 | Beijing Foyou Pharma CO.,LTD |
| 2025/10/21Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2500189 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | GenSci142胶囊 · No verified English nameCXSL2500912 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | GenSci142胶囊 · No verified English nameCXSL2500911 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | GenSci142胶囊 · No verified English nameCXSL2500910 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/10/21New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2500908 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | PT199 · No verified English nameCXSL2500907 | Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | cmRNA1210 注射液 · No verified English nameCXSL2500906 | Suzhou Ke Rui Mai De Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2501148 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2501147 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2501146 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2025/10/21New drug · Class 2.3 | 普卢格列汀达格列净二甲双胍缓释片 · No verified English nameCXHL2501145 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/10/21New drug · Class 2.3 | 普卢格列汀达格列净二甲双胍缓释片 · No verified English nameCXHL2501144 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/10/21New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2501143 | Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized |
| 2025/10/21New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2501142 | Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized |
| 2025/10/20New drug · Class 1 | EPI-003注射液 · No verified English nameCXSL2500909 | Yi Jie Li Ke (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/10/18Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSL2500206 | Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2500205 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2500204 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2500203 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Generic · Class 3 | 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503739 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2025/10/18Generic · Class 3 | 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503738 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2025/10/18Generic · Class 3 | 呋喃妥因胶囊 · No verified English nameCYHS2503732 | Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized |
124 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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