YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 392 drug applications between 5 April 2025 and 11 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 82 drug names.
2025/04/05 – 2025/04/11
- New acceptances this week
- 392
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 39
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
392filings, 114 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 114 |
| New drug | 61 |
| Import | 23 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| TCM | 82 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 4 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Dopamine Hydrochloride Injection | 4 | 2 | 3 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 6 | 复方聚乙二醇(3350)电解质散 · No verified English name | 2 | 2 | 3 |
| 7 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 5 |
| 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
248 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Bayer Inc. | 6 | 1 | 0 |
| 6 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 3 | 0 |
| 9 | Merck Healthcare KGaA | 5 | 3 | 0 |
| 10 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 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
123 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2025/04/11Generic · Class 3 | Acetylcysteine TabletsCYHS2501401 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/04/11Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501398 | Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized |
| 2025/04/11Generic · Class 3 | 聚乙二醇4000散 · No verified English nameCYHS2501395 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized |
| 2025/04/11Generic · Class 3 | Piracetam InjectionCYHS2501394 | Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | 注射用HY0001a · No verified English nameCXSL2500294 | Name not romanized |
| 2025/04/11New drug · Class 1 | CRG-B191注射液 · No verified English nameCXSL2500293 | Shanghai Ke Rui Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | XKH001注射液 · No verified English nameCXSL2500292 | Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | XKH001注射液 · No verified English nameCXSL2500291 | Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | PM1300注射用冻干制剂 · No verified English nameCXSL2500290 | Zhuhai Pu Mi Si Bio Technology Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/04/11New drug · Class 3.3 | 人生长激素注射液 · No verified English nameCXSL2500289 | Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | QX029N注射液 · No verified English nameCXSL2500288 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/11New drug · Class 2.3 | PXT3003 · No verified English nameCXHS2500027 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized |
| 2025/04/11New drug · Class 2.4 | 盐酸羟钴胺注射液 · No verified English nameCXHL2500382 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | 抗菌肽PL-3301口腔凝胶 · No verified English nameCXHL2500381 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized; Nanjing Di Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | 抗菌肽PL-3301口腔凝胶 · No verified English nameCXHL2500380 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized; Nanjing Di Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | HRS-8829注射用浓溶液 · No verified English nameCXHL2500379 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | 艾本那肽注射液 · No verified English nameCXHL2500378 | Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized |
| 2025/04/11New drug · Class 1 | HRS-9821吸入粉雾剂 · No verified English nameCXHL2500377 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Bumetanide InjectionCYHS2501389 | Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Celecoxib TabletsCYHS2501388 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Minodronic acid TabletsCYHS2501386 | Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501384 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501383 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Ferrous Succinate TabletsCYHS2501379 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/04/10New drug · Class 1.1 | 健脾解毒丸 · No verified English nameCXZL2500021 | Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized |
| 2025/04/10New drug · Class 1 | LNF2102注射液 · No verified English nameCXSL2500287 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
93 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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