YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 261 drug applications between 24 September 2026 and 30 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 34 drug names.
2026/09/24 – 2026/09/30
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 218
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
261filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 136 |
| New drug | 50 |
| Generic | 39 |
| Import | 24 |
| Import re-registration | 9 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| TCM | 81 |
| Therapeutic biologic | 40 |
| Biologic | 2 |
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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Edaravone and Dexborneol Concentrated Solution for Injection | 3 | 3 | 34 |
| 2 | Dotinurad Tablets | 2 | 1 | 55 |
| 3 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 4 | Atorvastatin Calcium Tablets | 2 | 1 | 24 |
| 5 | ω-3 Fish Oil Fat Emulsion Injection | 1 | 1 | 6 |
| 6 | Acetylcysteine Tablets | 1 | 1 | 8 |
| 7 | Sodium Ibandronate Injection | 1 | 1 | 4 |
| 8 | 利多卡因丙胺卡因气雾剂 · No verified English name | 1 | 1 | 5 |
| 9 | Dexketoprofen Trometamol Injection | 1 | 1 | 6 |
| 10 | 复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液 · No verified English name | 1 | 1 | 2 |
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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 16 | 3 | 0 |
| 2 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Shanxi Wang Long Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Shaanxi Ou Ke Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Anhui Zhang Heng Chun Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Shen Wei Pharma Group Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Yunnan Zhi Wu Pharma Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Hangzhou Du Yi Technology 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/30Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2600262 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/09/30Generic · Class 3 | Acetylcysteine TabletsCYHS2602434 | Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized |
| 2026/09/30Generic · Class 3 | Levofloxacin InjectionCYHS2602433 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | 注射用AST1001 · No verified English nameCXSL2601080 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | RG002-03注射液 · No verified English nameCXSL2601079 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2026/09/30New drug · Class 1 | ALXN2220注射液 · No verified English nameCXSL2601078 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SI-B037双特异性抗体注射液 · No verified English nameCXSL2601077 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/09/30New drug · Class 2.2; 2.4 | BTS1115 · No verified English nameCXHL2601220 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SPR2015片 · No verified English nameCXHL2601219 | Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SPR2015片 · No verified English nameCXHL2601218 | Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | HJY-39注射液 · No verified English nameCXHL2601217 | Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600435 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600434 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600433 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600432 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600431 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600430 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600429 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Generic · Class 3 | Calcitriol Oral SolutionCYHS2602431 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | Hydrotalcite SuspensionCYHS2602427 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | 多种微量元素注射液(IV) · No verified English nameCYHS2602425 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | Simethicone Chewable TabletsCYHS2602422 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 3.4 | 替瑞奇珠单抗注射液 · No verified English nameCXSS2600157 | Cheng Hua Pharma (Hainan) Co., Ltd. romanized; Xia Er Ba Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | HL99自体T细胞注射液 · No verified English nameCXSL2601076 | Henan Sheng Hua Long Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | SIM0725注射液 · No verified English nameCXSL2601075 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用SIM0505 · No verified English nameCXSL2601074 | Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用BG-T187(皮下注射) · No verified English nameCXSL2601073 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用YL413 · No verified English nameCXSL2601072 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用HCRB001 · No verified English nameCXSL2601071 | Haikou Tie Shu Da Fang Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | MK-8748眼内注射溶液 · No verified English nameCXSL2601070 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
62 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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