YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 17 February 2025 and 23 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 59 drug names.
2025/02/17 – 2025/02/23
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 14
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
304filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 83 |
| New drug | 50 |
| Import | 15 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 49 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 4 |
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
59 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 | 盐酸舍曲林口服浓缩液 · No verified English name | 2 | 2 | 3 |
| 6 | Multiple Electrolytes and Sodium Acetate Injection | 2 | 1 | 4 |
| 7 | 多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed. | 2 | 1 | 0 |
| 8 | 氯雷他定口服溶液 · No verified English name | 2 | 1 | 3 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
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
190 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 | 7 | 7 | 0 |
| 5 | Hebei Hua Chen Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 4 |
| 7 | Hua Chuan Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | 4 | 3 | 2 |
| 9 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 3 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/22Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2500823 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2500820 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/02/22Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500819 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500818 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2500817 | Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | Peramivir InjectionCYHS2500816 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2500814 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2500050 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/22Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2500049 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/22New drug · Class 2.2 | 伊匹木单抗注射液 · No verified English nameCXSS2500032 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/02/22New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2500031 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/02/22New drug · Class 1 | 注射用QLS5132 · No verified English nameCXSL2500173 | Qilu Pharmaceutical Co., Ltd. |
| 2025/02/22New drug · Class 2.2; 2.4 | 优替德隆胶囊 · No verified English nameCXHL2500214 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/22New drug · Class 2.2 | X001 干混悬剂 · No verified English nameCXHL2500213 | Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/02/22New drug · Class 1 | TFX06片 · No verified English nameCXHL2500212 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/22New drug · Class 1 | TFX06片 · No verified English nameCXHL2500211 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
70 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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