YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 473 drug applications between 16 October 2025 and 22 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 58 drug names.
2025/10/16 – 2025/10/22
- New acceptances this week
- 473
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 115
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
473filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 285 |
| Generic | 80 |
| New drug | 74 |
| Import | 18 |
| Unspecified | 11 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 306 |
| TCM | 85 |
| Therapeutic biologic | 71 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
| 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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 4 | 4 | 51 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 4 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 5 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 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 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
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
258 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 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Topfond Pharmaceutical Co., Ltd. | 5 | 5 | 0 |
| 7 | Tong Hua Si Wei Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 9 | Sanofi-Aventis Recherche & Développement | 5 | 2 | 0 |
| 10 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 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
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/22Import · Class 3.1 | 艾普奈珠单抗注射用浓溶液 · No verified English nameJXSS2500134 | Lundbeck Seattle BioPharmaceuticals Inc.; Vetter Pharma-Fertigung GmbH & Co.KG; Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd. |
| 2025/10/22Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2503760 | Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized |
| 2025/10/22Generic · Class 3 | Furosemide Oral SolutionCYHS2503758 | Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized |
| 2025/10/22Generic · Class 3 | Labetalol Hydrochloride TabletsCYHS2503757 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/10/22Generic · Class 3 | Acetylcysteine TabletsCYHS2503754 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2025/10/22New drug · Class 3.1 | 半夏白术天麻颗粒 · No verified English nameCXZS2500047 | Sichuan Guang Da Pharmaceutical Co., Ltd. romanized |
| 2025/10/22New drug · Class 3.1 | 真武汤颗粒 · No verified English nameCXZS2500046 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2025/10/22New drug · Class 1.1 | 舒肝安胃颗粒 · No verified English nameCXZL2500102 | Beijing Wei Wei Kang Technology Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | SIM0278注射液 · No verified English nameCXSL2500918 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized |
| 2025/10/22New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500917 | Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | IMM2510 · No verified English nameCXSL2500916 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500915 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | IMM2510 · No verified English nameCXSL2500914 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | NRG-103注射液 · No verified English nameCXSL2500913 | Niu Lun Jie Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | 索特替尼片 · No verified English nameCXHS2500126 | Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd. |
| 2025/10/22New drug · Class 1 | 索特替尼片 · No verified English nameCXHS2500125 | Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd. |
| 2025/10/22New drug · Class 2.1; 2.2 | CMCY2304口崩片 · No verified English nameCXHL2501156 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/10/22New drug · Class 2.1; 2.2 | CMCY2304口崩片 · No verified English nameCXHL2501155 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | HRS-2141片(II) · No verified English nameCXHL2501154 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | HRS-2141片(I) · No verified English nameCXHL2501153 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | SYH2072片 · No verified English nameCXHL2501152 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | SYH2072片 · No verified English nameCXHL2501151 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | SYH2072片 · No verified English nameCXHL2501150 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/22New drug · Class 1 | SYH2072片 · No verified English nameCXHL2501149 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
91 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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