YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 398 drug applications between 14 August 2025 and 20 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 78 drug names.
2025/08/14 – 2025/08/20
- New acceptances this week
- 398
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 102
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
398filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 109 |
| New drug | 85 |
| Import | 20 |
| Unspecified | 15 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 253 |
| TCM | 67 |
| Therapeutic biologic | 67 |
| Biologic | 6 |
| Prophylactic biologic | 5 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡格列净二甲双胍缓释片 · No verified English name | 4 | 1 | 5 |
| 2 | Bifonazole Solution | 3 | 3 | 15 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Trazodone Hydrochloride Sustained-release Tablets | 3 | 2 | 20 |
| 5 | Mirogabalin Besilate Tablets | 3 | 2 | 61 |
| 6 | Lactulose Oral Solution | 3 | 1 | 34 |
| 7 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 8 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 9 | Folic Acid Tablets | 2 | 2 | 12 |
| 10 | Letermovir Tablets | 2 | 2 | 7 |
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
252 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 8 | 4 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 6 | 2 | 3 |
| 5 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Bristol-Myers Squibb Pharma EEIG | 4 | 2 | 0 |
| 8 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 9 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 10 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 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
141 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/20Import · Class 3.1 | 阿伏利尤单抗注射液 · No verified English nameJXSS2500109 | AstraZeneca AB; AstraZeneca Nijmegen B.V.; AstraZeneca Investment (China) Co. Ltd. |
| 2025/08/20Import · Class 1 | AZD2936 · No verified English nameJXSL2500156 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500220 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500219 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500218 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503066 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Potassium Chloride InjectionCYHS2503058 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Magnesium Sulfate InjectionCYHS2503057 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Magnesium Sulfate InjectionCYHS2503055 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | 左乙拉西坦微片 · No verified English nameCYHS2503054 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | 左乙拉西坦微片 · No verified English nameCYHS2503053 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Pentoxifylline InjectionCYHS2503052 | Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2503051 | Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2025/08/20New drug · Class 3.1 | 保元汤颗粒 · No verified English nameCXZS2500035 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/08/20New drug · Class 1 | 注射用CS2009 · No verified English nameCXSL2500727 | Shen Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | AZD0901 · No verified English nameCXSL2500726 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | AZD0901 · No verified English nameCXSL2500725 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/08/20New drug · Class 1.3 | 吸附无细胞百(二组分)白破联合疫苗(成人及青少年用) · No verified English nameCXSL2500724 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2025/08/20New drug · Class 3.3 | PJ021注射液 · No verified English nameCXSL2500723 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | SYS6010 · No verified English nameCXSL2500722 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | NH600001乳状注射液 · No verified English nameCXHS2500099 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2500098 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2500097 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2025/08/20New drug · Class 2.2 | TH202216胶束注射液 · No verified English nameCXHL2500879 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | BGT-004乳膏 · No verified English nameCXHL2500878 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/20New drug · Class 1 | BGT-004乳膏 · No verified English nameCXHL2500877 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503045 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503040 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503039 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503038 | Le Pu Pharma Co., Ltd. romanized |
111 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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