YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 427 drug applications between 4 September 2025 and 10 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 80 drug names.
2025/09/04 – 2025/09/10
- New acceptances this week
- 427
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 122
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
427filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 119 |
| New drug | 74 |
| Import | 37 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| TCM | 81 |
| Therapeutic biologic | 70 |
| Biologic | 4 |
| Prophylactic 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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 3 | 70 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | 左羟丙哌嗪口服溶液 · No verified English name | 3 | 1 | 8 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Ibrutinib Capsules | 2 | 2 | 9 |
| 7 | Pemafibrate Tablets | 2 | 2 | 23 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
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 | Eli Lilly and Company | 13 | 3 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 10 | 5 | 2 |
| 3 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 9 | 7 | 0 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 7 | 7 | 0 |
| 5 | Pfizer Inc. | 7 | 3 | 0 |
| 6 | Janssen Research & Development LLC | 7 | 1 | 0 |
| 7 | AstraZeneca AB | 6 | 3 | 0 |
| 8 | Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Shanghai Ao Ke Da Pharmaceuticals Technology 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
150 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/10Import · Class 1 | Empasiprubart注射用浓溶液 · No verified English nameJXSL2500173 | argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500275 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500274 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500273 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500272 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500271 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHL2500270 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/10Import · Class 1 | PF-07799933片 · No verified English nameJXHL2500269 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/10Import · Class 1 | PF-07799933片 · No verified English nameJXHL2500268 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/10Import · Class 1 | PF-07799544片 · No verified English nameJXHL2500267 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/10Import · Class 1 | PF-07799544片 · No verified English nameJXHL2500266 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/10Import · Class 1 | PF-07799544片 · No verified English nameJXHL2500265 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/10Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2503357 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2025/09/10Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2503355 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/09/10Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2503354 | Tianjin Bio Chemical Pharmaceutical Co., Ltd. romanized |
| 2025/09/10Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2503352 | Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/09/10Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2503343 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/09/10Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2503342 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/09/10New drug · Class 3.1 | 开心散 · No verified English nameCXZS2500037 | Guo Yao Group Zhong Lian Pharma Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | 注射用HMPL-A251 · No verified English nameCXSL2500784 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | FS-8002注射液 · No verified English nameCXSL2500783 | Shanghai Pu Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | AWT020注射用无菌粉末 · No verified English nameCXSL2500782 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 2.1 | SHR-A1811(sc)注射液 · No verified English nameCXSL2500781 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | 注射用JS212 · No verified English nameCXSL2500780 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | 注射用GEN1184 · No verified English nameCXSL2500779 | Jin Mai An Bo Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2500778 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | AP-L1898胶囊 · No verified English nameCXHL2500988 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 2.4 | 多黏菌素E甲磺酸钠吸入粉雾剂 · No verified English nameCXHL2500987 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | JK0002乳膏 · No verified English nameCXHL2500986 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2025/09/10New drug · Class 1 | JK0002乳膏 · No verified English nameCXHL2500985 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
120 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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