YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 647 drug applications between 16 September 2026 and 22 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 68 drug names.
2026/09/16 – 2026/09/22
- New acceptances this week
- 647
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 535
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
647filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 359 |
| New drug | 121 |
| Generic | 100 |
| Import | 29 |
| Import re-registration | 20 |
| Unspecified | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 320 |
| TCM | 196 |
| Therapeutic biologic | 119 |
| Biologic | 11 |
| 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | Ruxolitinib Phosphate Tablets | 4 | 1 | 27 |
| 3 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 4 | Brimonidine Tartrate Eye Drops | 3 | 3 | 4 |
| 5 | Emedastine Difumarate Sustained-release Capsules | 3 | 2 | 11 |
| 6 | 司美格鲁肽注射液 · No verified English name | 3 | 1 | 92 |
| 7 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 8 | Mupirocin Ointment | 3 | 1 | 30 |
| 9 | 盐酸西替利嗪滴眼液 · No verified English name | 2 | 2 | 3 |
| 10 | Fruquintinib Capsules | 2 | 1 | 4 |
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
363 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 13 | 3 | 0 |
| 2 | Janssen-Cilag International NV | 10 | 3 | 0 |
| 3 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 4 | Bayer Vital GmbH | 9 | 1 | 0 |
| 5 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 8 | 7 | 0 |
| 6 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 7 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 7 | 5 | 0 |
| 8 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 7 | 2 | 0 |
| 9 | Jiangsu Lian Huan Zhong Yao Co., Ltd. romanized | 6 | 4 | 0 |
| 10 | Novo Nordisk A/S | 6 | 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
169 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/22Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2600256 | Merck Sharp & Dohme LLC; Name not romanized |
| 2026/09/22Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602384 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jiangxi Ke Lun Pharma Co., Ltd. romanized |
| 2026/09/22Generic · Class 3 | 地塞米松口服溶液 · No verified English nameCYHS2602383 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/22Generic · Class 3 | Brimonidine Tartrate Eye DropsCYHL2600102 | Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized |
| 2026/09/22New drug · Class 1.1 | HG1101颗粒 · No verified English nameCXZL2600093 | He Guang Zhong Yao Technology (Tianjin) Co., Ltd. romanized |
| 2026/09/22New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2600153 | Hua Lan An Kang Bio Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | 9MW5211注射液 · No verified English nameCXSL2601051 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | N69胶囊 · No verified English nameCXSL2601050 | Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 3.2 | 人C1酯酶抑制剂 · No verified English nameCXSL2601049 | Guo Yao Group Wuhan Biopharmaceutical Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | 注射用DB-1323 · No verified English nameCXSL2601048 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | 注射用BG-C477 · No verified English nameCXSL2601047 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/09/22New drug · Class 2.2 | 斯鲁利单抗注射液 · No verified English nameCXSL2601046 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | NTS231片 · No verified English nameCXHL2601194 | Shanghai Yu Dao Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | NTS231片 · No verified English nameCXHL2601193 | Shanghai Yu Dao Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | K-119肠溶片 · No verified English nameCXHL2601192 | Shanghai Rui Le Jin Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | K-119肠溶片 · No verified English nameCXHL2601191 | Shanghai Rui Le Jin Bio Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | JCSH-021片 · No verified English nameCXHL2601190 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | JCSH-021片 · No verified English nameCXHL2601189 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized |
| 2026/09/22New drug · Class 1 | JCSH-021片 · No verified English nameCXHL2601188 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized |
| 2026/09/21Import · Class 1 | SAR448632注射用粉末 · No verified English nameJXSL2600255 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/21Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2602374 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602367 | Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602365 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602359 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2026/09/21Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2602358 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2026/09/21New drug · Class 1 | YT003注射液 · No verified English nameCXSL2601045 | Beijing Yong Tai Bio Zhi Pin Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | BT02单克隆抗体注射液 · No verified English nameCXSL2601044 | Shanghai Bai Quan Bio Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | HS-IT101注射液 · No verified English nameCXSL2601043 | Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | 注射用TQB6411 · No verified English nameCXSL2601042 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/21New drug · Class 1 | SHR-4506注射液 · No verified English nameCXSL2601041 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
139 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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