YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 10 April 2025 and 16 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 67 drug names.
2025/04/10 – 2025/04/16
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 38
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
347filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 97 |
| New drug | 55 |
| Import | 19 |
| Unspecified | 4 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 63 |
| Therapeutic biologic | 47 |
| Prophylactic biologic | 5 |
| 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
67 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 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Cefotaxime Sodium For Injection | 4 | 1 | 14 |
| 4 | 达普司他片 · No verified English name | 4 | 1 | 0 |
| 5 | 复方聚乙二醇(3350)电解质散 · No verified English name | 3 | 2 | 3 |
| 6 | Finerenone Tablets | 3 | 2 | 69 |
| 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 | Iron Proteinsuccinylate Oral Solution | 2 | 2 | 26 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 9 | 5 | 0 |
| 2 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 8 | 5 | 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 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 9 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Qilu Pharmaceutical (Hainan) Co., Ltd | 4 | 1 | 4 |
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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2025/04/16Import · Class 1 | BMS-986435片 · No verified English nameJXHL2500086 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/04/16Import · Class 1 | BMS-986435片 · No verified English nameJXHL2500085 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/04/16Import · Class 1 | BMS-986435片 · No verified English nameJXHL2500084 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/04/16Import · Class 2.4 | Olaparib TabletsJXHL2500083 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/04/16Import · Class 2.4 | Olaparib TabletsJXHL2500082 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/04/16Generic · Class 3 | Deferasirox GranulesCYHS2501457 | Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/04/16Generic · Class 3 | Deferasirox GranulesCYHS2501455 | Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/04/16Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501449 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501448 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501446 | Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501445 | Chengdu Giantech Hi-technology Development Co., Ltd.; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2501443 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2501442 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2501441 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2501440 | Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2501439 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized |
| 2025/04/16Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500085 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/04/16Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500084 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/04/16Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500083 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/04/16Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500082 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/04/16New drug · Class 2.3 | 小儿黄金止咳颗粒 · No verified English nameCXZL2500023 | Beijing Dong Fang Yun Jia Pharma Co., Ltd. romanized |
| 2025/04/16New drug · Class 1.1 | 益气活血解郁颗粒 · No verified English nameCXZL2500022 | Hangzhou Hong Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/16New 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 nameCXSL2500309 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2025/04/16New drug · Class 1 | DMR2301注射液 · No verified English nameCXSL2500308 | Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized |
| 2025/04/16New drug · Class 1 | SCTB39G注射液 · No verified English nameCXSL2500307 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/04/16New drug · Class 3.3 | 甘精胰岛素注射液 · No verified English nameCXSL2500306 | Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized |
79 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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