YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 521 drug applications between 30 July 2026 and 5 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 57 drug names.
2026/07/30 – 2026/08/05
- New acceptances this week
- 521
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 206
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
521filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 280 |
| New drug | 98 |
| Generic | 84 |
| Import | 38 |
| Unspecified | 12 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| TCM | 180 |
| Therapeutic biologic | 89 |
| Biologic | 4 |
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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 4 | 2 | 26 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Nafamostat Mesilate for Injection | 3 | 2 | 38 |
| 4 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 5 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 6 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 7 | Fluvastatin Sodium Extended Release Tablets | 2 | 2 | 6 |
| 8 | 盐酸氮?斯汀鼻喷雾剂 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified. | 2 | 2 | 7 |
| 9 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 10 | Dotinurad Tablets | 2 | 1 | 55 |
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
290 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 | AbbVie Inc. | 9 | 6 | 0 |
| 4 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Li Zhu Group Li Min Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 3 |
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
161 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/08/05New drug · Class 3.1 | 当归建中汤颗粒 · No verified English nameCXZS2600041 | Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600836 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | SHR-4849注射液 · No verified English nameCXSL2600835 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | 重组人源化抗FXI双特异性抗体注射液 · No verified English nameCXSL2600834 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | 注射用NW001 · No verified English nameCXSL2600833 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Xin Yu Bio Technology Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2600832 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2600831 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | SYS6043 · No verified English nameCXSL2600830 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2600829 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2600828 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | 注射用GEN1184 · No verified English nameCXSL2600827 | Jin Mai An Bo Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600826 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600825 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600824 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600823 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | IBI3002 · No verified English nameCXSL2600822 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/05New drug · Class 1 | ES502注射液 · No verified English nameCXSL2600821 | Shanghai Ling Shi Zhi Yuan Bio Technology Co., Ltd. romanized |
131 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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