YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 484 drug applications between 31 July 2026 and 6 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 61 drug names.
2026/07/31 – 2026/08/06
- New acceptances this week
- 484
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 202
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
484filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 257 |
| New drug | 92 |
| Generic | 86 |
| Import | 32 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 172 |
| Therapeutic biologic | 75 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 2 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 4 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 5 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 6 | Fluvastatin Sodium Extended Release Tablets | 2 | 2 | 6 |
| 7 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 8 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 9 | Dotinurad Tablets | 2 | 1 | 55 |
| 10 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
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
276 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 18 | 17 | 0 |
| 2 | Eli Lilly and Company | 11 | 2 | 0 |
| 3 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Bayer Inc. | 6 | 1 | 0 |
| 7 | Li Zhu Group Li Min Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | Hubei Dong Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | AbbVie Inc. | 5 | 3 | 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
146 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600328 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600327 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600326 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2601919 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/08/06Generic · Class 3 | 琥珀酸索利那新口服混悬液 · No verified English nameCYHS2601913 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 2.1 | 万通筋骨巴布膏 · No verified English nameCXZS2600042 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2026/08/06New drug · Class 1.1 | YJZ11031颗粒 · No verified English nameCXZL2600070 | Beijing Dong Fang Yun Jia Pharma Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | 注射用SSGJ-709 · No verified English nameCXSL2600841 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | FG-M108注射液 · No verified English nameCXSL2600840 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2600839 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2600838 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | 注射用JSKN022 · No verified English nameCXSL2600837 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | XNW26018片 · No verified English nameCXHL2600974 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | XNW26018片 · No verified English nameCXHL2600973 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 1 | ADC118片 · No verified English nameCXHL2600972 | Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 2.2; 2.4 | CB345 · No verified English nameCXHL2600971 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 2.2; 2.4 | CB345 · No verified English nameCXHL2600970 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/05Import · Class 1 | JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600188 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/08/05Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2600187 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/08/05Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2600186 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/08/05Import · Class 1 | DDY391片 · No verified English nameJXHL2600325 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/05Import · Class 1 | DDY391片 · No verified English nameJXHL2600324 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/05Import · Class 1 | DDY391片 · No verified English nameJXHL2600323 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/05Generic · Class 3 | Pregabalin Extended release TabletsCYHS2601907 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | Amoxicillin CapsulesCYHS2601906 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | Amoxicillin CapsulesCYHS2601905 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2601901 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2601900 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2601899 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/08/05Generic · Class 3 | 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHL2600086 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized |
116 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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