YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 289 drug applications between 15 February 2025 and 21 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 54 drug names.
2025/02/15 – 2025/02/21
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 15
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
289filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 75 |
| New drug | 47 |
| Import | 17 |
| Unspecified | 6 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 46 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 5 | 3 | 27 |
| 2 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 4 | 2 | 4 |
| 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules | 4 | 1 | 2 |
| 4 | Brexpiprazole Tablets | 3 | 2 | 31 |
| 5 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 6 | Multiple Electrolytes and Sodium Acetate Injection | 2 | 1 | 4 |
| 7 | 氯雷他定口服溶液 · No verified English name | 2 | 1 | 3 |
| 8 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 9 | Trelagliptin Succinate Tablets | 2 | 1 | 1 |
| 10 | 盐酸西替利嗪滴剂 · No verified English name | 2 | 1 | 8 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Janssen-Cilag International NV | 12 | 4 | 0 |
| 3 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 10 | 6 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Hebei Hua Chen Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 9 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 3 | 3 | 3 |
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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/21Import · Class 3.1 | Tremelimumab注射液 · No verified English nameJXSS2500016 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | Tremelimumab注射液 · No verified English nameJXSS2500015 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500014 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500013 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/02/21Generic · Class 3 | Acetylcysteine InjectionCYHS2500813 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2025/02/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500812 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/02/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2500811 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/02/21Generic · Class 3 | Valganciclovir Hydrochloride Powder For Oral SolutionCYHS2500808 | Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/02/21New drug · Class 1 | TAEST1901注射液 · No verified English nameCXSL2500172 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
| 2025/02/21New drug · Class 2.2 | 吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameCXSL2500171 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2025/02/21New drug · Class 1 | Afuresertib片 · No verified English nameCXHL2500210 | Lai Kai Pharmaceutical (Ningbo) Co., Ltd. romanized |
| 2025/02/21New drug · Class 1 | Afuresertib片 · No verified English nameCXHL2500209 | Lai Kai Pharmaceutical (Ningbo) Co., Ltd. romanized |
| 2025/02/21New drug · Class 1 | WXSH0493片 · No verified English nameCXHL2500208 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/02/20Import · Class 2.4 | 硫酸氢司美替尼胶囊 · No verified English nameJXHS2500026 | ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd |
| 2025/02/20Import · Class 2.4 | 硫酸氢司美替尼胶囊 · No verified English nameJXHS2500025 | ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd |
| 2025/02/20Import · Class 1 | ABBV-932胶囊 · No verified English nameJXHL2500029 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/02/20Import · Class 1 | ABBV-932胶囊 · No verified English nameJXHL2500028 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/02/20Import · Class 1 | ABBV-932胶囊 · No verified English nameJXHL2500027 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/02/20Generic · Class 3 | 小儿多种维生素注射液(13) · No verified English nameCYHS2500807 | Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2025/02/20Generic · Class 3 | 氯雷他定口服溶液 · No verified English nameCYHS2500803 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/02/20Generic · Class 3 | 氯雷他定口服溶液 · No verified English nameCYHS2500802 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/02/20Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2500798 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2025/02/20New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2500030 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/02/20New drug · Class 2.1 | SHR-1316(sc)注射液 · No verified English nameCXSL2500170 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/20New drug · Class 1 | 注射用CS5001 · No verified English nameCXSL2500169 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/02/20New drug · Class 1.2 | 重组破伤风疫苗(大肠埃希菌) · No verified English nameCXSL2500168 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized; Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized |
| 2025/02/20New drug · Class 1 | 注射用MHB046C · No verified English nameCXSL2500167 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/02/20New drug · Class 1 | 注射用BGB-R046 · No verified English nameCXSL2500166 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/02/20New drug · Class 2.2 | AX23104口崩片 · No verified English nameCXHL2500207 | Beijing Hai Yi Pharma Co., Ltd. romanized |
| 2025/02/20New drug · Class 1 | MT2004胶囊 · No verified English nameCXHL2500206 | Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized |
62 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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