YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 337 drug applications between 11 April 2025 and 17 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 64 drug names.
2025/04/11 – 2025/04/17
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 31
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
337filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 90 |
| New drug | 57 |
| Import | 17 |
| Import re-registration | 12 |
| Unspecified | 4 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 54 |
| Therapeutic biologic | 46 |
| Prophylactic biologic | 3 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 5 | 2 | 70 |
| 2 | Cefotaxime Sodium For Injection | 4 | 1 | 14 |
| 3 | 达普司他片 · No verified English name | 4 | 1 | 0 |
| 4 | 复方聚乙二醇(3350)电解质散 · No verified English name | 3 | 2 | 3 |
| 5 | Finerenone Tablets | 3 | 2 | 69 |
| 6 | Riociguat Tablets | 3 | 1 | 4 |
| 7 | Ampicillin Sodium For Injection | 3 | 1 | 5 |
| 8 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 9 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 10 | Deferasirox Granules | 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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 8 | 5 | 0 |
| 2 | AstraZeneca AB | 7 | 5 | 0 |
| 3 | Kowa Company Ltd. | 5 | 1 | 0 |
| 4 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 5 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 5 | 1 | 0 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 7 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 8 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 9 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/17Generic · Class 3 | Calcium Carbonate TabletsCYHS2501473 | Zhong He Pharmaceuticals (Hubei) Co., Ltd. romanized; Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Bumetanide InjectionCYHS2501471 | Shandong Hui Cheng Pharma Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2501466 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2501465 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Indobufen TabletsCYHS2501464 | Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501463 | Hebei Hong Xin Tang Pharma Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized |
| 2025/04/17Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2501461 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | 注射用HY05350 · No verified English nameCXSL2500316 | Name not romanized |
| 2025/04/17New drug · Class 1 | J002 · No verified English nameCXSL2500315 | Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | J002 · No verified English nameCXSL2500314 | Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | YOLT-101注射液 · No verified English nameCXSL2500313 | Yao Tang (Nanjing) Bio Technology Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | HF158K1 · No verified English nameCXSL2500312 | Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | HFK2 · No verified English nameCXSL2500311 | Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | SSS55注射液 · No verified English nameCXSL2500310 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | PTT-621片 · No verified English nameCXHL2500399 | Beijing Yan Ming Bio Technology Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | PTT-621片 · No verified English nameCXHL2500398 | Beijing Yan Ming Bio Technology Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | WBD156胶囊 · No verified English nameCXHL2500397 | Wei En Bio Technology Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | WBD156胶囊 · No verified English nameCXHL2500396 | Wei En Bio Technology Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | WBD156胶囊 · No verified English nameCXHL2500395 | Wei En Bio Technology Co., Ltd. romanized |
| 2025/04/17New drug · Class 2.2 | CX001缓释片 · No verified English nameCXHL2500394 | Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 2.2 | CX001缓释片 · No verified English nameCXHL2500393 | Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 2.2 | CX001缓释片 · No verified English nameCXHL2500392 | Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | HSK45030分散片 · No verified English nameCXHL2500391 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | HSK45030分散片 · No verified English nameCXHL2500390 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | 102D-6干混悬剂 · No verified English nameCXHL2500389 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized |
| 2025/04/17New drug · Class 1 | BW-20507注射液 · No verified English nameCXHL2500388 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Import · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameJXSS2500048 | inibio co. ltd.; Beijing Yuzhuo Biotechnology Co. Ltd. |
| 2025/04/16Import · Class 3.1 | 米吉珠单抗注射液 · No verified English nameJXSS2500047 | Eli Lilly and Company; BSP Pharmaceuticals S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/16Import · Class 3.1 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2500046 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/16Import · Class 3.1 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2500045 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
82 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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