YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 335 drug applications between 9 April 2025 and 15 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 76 drug names.
2025/04/09 – 2025/04/15
- New acceptances this week
- 335
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 37
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
335filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 101 |
| New drug | 49 |
| Import | 18 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 64 |
| Therapeutic biologic | 31 |
| 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
76 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 | Dopamine Hydrochloride Injection | 4 | 2 | 3 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Ampicillin Sodium For Injection | 3 | 1 | 5 |
| 5 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 6 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 7 | Iguratimod Tablets | 2 | 2 | 23 |
| 8 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 9 | Iron Proteinsuccinylate Oral Solution | 2 | 2 | 26 |
| 10 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 5 |
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
221 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 8 | 5 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 7 | 4 | 0 |
| 5 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 7 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 5 | 1 | 0 |
| 8 | Takeda Pharmaceuticals U.S.A. Inc. | 4 | 2 | 0 |
| 9 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Hua Yi Tai Kang Pharma 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/15Import · Class 2.4 | Seladelpar胶囊 · No verified English nameJXHL2500081 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2025/04/15Import · Class 2.4 | Seladelpar胶囊 · No verified English nameJXHL2500080 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2025/04/15Import · Class 1 | AZD6234注射液 · No verified English nameJXHL2500079 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/15Import · Class 1 | AZD9550注射液 · No verified English nameJXHL2500078 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/15Import · Class 1 | AZD9550注射液 · No verified English nameJXHL2500077 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/15Generic · Class 3 | 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2501431 | Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2025/04/15Generic · Class 3 | Potassium Aspartate InjectionCYHS2501430 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/04/15Generic · Class 3 | Simethicone Chewable TabletsCYHS2501429 | Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized |
| 2025/04/15New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSS2500045 | Nan Yue Biopharmaceutical Co., Ltd. romanized |
| 2025/04/15New drug · Class 1 | SHR-2173注射液 · No verified English nameCXSL2500298 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/15New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500297 | Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized |
| 2025/04/15New drug · Class 1 | KY2液体硬胶囊 · No verified English nameCXHL2500387 | Shenzhen Kai Yue Sheng Ming Technology Co., Ltd. romanized |
| 2025/04/15New drug · Class 1 | YJH-012注射液 · No verified English nameCXHL2500386 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized |
| 2025/04/14Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2501427 | Shandong An Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/14Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2501426 | Shandong An Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/14Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2501425 | Shandong An Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/14Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2501424 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/04/14Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2500080 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized |
| 2025/04/14New drug · Class 2.1 | GD-19乳状注射液 · No verified English nameCXHL2500385 | Tianjin Gu Dui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/12Generic · Class 3 | Multiple Vitamins InjectionCYHS2501413 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/04/12Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501410 | Hubei Cheng Jian Pharma Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized |
| 2025/04/12Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2501408 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/04/12New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2500296 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2025/04/12New drug · Class 1 | 注射用RGL-232 · No verified English nameCXSL2500295 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2025/04/12New drug · Class 2.2 | LN2222 · No verified English nameCXHL2500384 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/04/12New drug · Class 2.2 | LN2222 · No verified English nameCXHL2500383 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/04/11Import · Class 1.4 | 21价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2500058 | Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2025/04/11Generic · Class 3 | Vitamin K1 InjectionCYHS2501407 | Hainan Quan Ying Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/04/11Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2501406 | Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized; Chongqing He Ping Pharmaceutical Co., Ltd. romanized |
| 2025/04/11Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2501404 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
71 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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