YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 380 drug applications between 26 January 2026 and 1 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 47 drug names.
2026/01/26 – 2026/02/01
- New acceptances this week
- 380
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 91
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
380filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 225 |
| Generic | 63 |
| New drug | 63 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 105 |
| Therapeutic biologic | 61 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
| In vitro diagnostic reagent | 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefmetazole Sodium for Injection | 3 | 1 | 7 |
| 2 | 莫立司他钠片 · No verified English name | 3 | 1 | 0 |
| 3 | 褪黑素颗粒 · No verified English name | 2 | 2 | 12 |
| 4 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 5 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 6 | 复方氨基酸注射液(17AA-Ⅲ) · No verified English name | 2 | 1 | 2 |
| 7 | 左羟丙哌嗪口服溶液 · No verified English name | 2 | 1 | 8 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Galantamine Hydrobromide Tablets | 2 | 1 | 2 |
| 10 | 注射用头孢他啶/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 14 | 7 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Shen Wei Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Novo Nordisk A/S | 6 | 1 | 0 |
| 7 | Pfizer Inc. | 4 | 4 | 0 |
| 8 | Dan Dong Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jiangxi Wang Shi Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Sanofi Winthrop Industrie | 4 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/31Import · Class 1 | PF-08634404 · No verified English nameJXSL2600036 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046047 · No verified English nameJXSL2600035 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2600034 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | BMS-986504片 · No verified English nameJXHL2600031 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/01/31Generic · Class 3 | Galantamine Hydrobromide TabletsCYHS2600329 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Galantamine Hydrobromide TabletsCYHS2600328 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Etoposide InjectionCYHS2600327 | Wuxi Zi Shan Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2600321 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Carbocisteine Oral SolutionCYHS2600320 | Chengdu Giantech Hi-technology Development Co., Ltd.; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/01/31Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2600319 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | 莫立司他钠片 · No verified English nameCYHL2600019 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | 莫立司他钠片 · No verified English nameCYHL2600018 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | 莫立司他钠片 · No verified English nameCYHL2600017 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2026/01/31New drug · Class 1.1 | 金柴胶囊 · No verified English nameCXZS2600010 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/01/31New drug · Class 3.1 | 清金化痰颗粒 · No verified English nameCXZS2600009 | Jiang Yin Tian Jiang Pharma Co., Ltd. romanized |
| 2026/01/31New drug · Class 3.1 | 黄芪桂枝五物汤颗粒 · No verified English nameCXZS2600008 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/01/31New drug · Class 1.1 | 地黄宝源颗粒 · No verified English nameCXZL2600020 | Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/31New drug · Class 1.1 | 地黄宝源颗粒 · No verified English nameCXZL2600019 | Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/31New drug · Class 1.1 | 茯苓运化颗粒 · No verified English nameCXZL2600018 | Jing Yi He Sheng Pharmaceuticals (Guangdong Heng Qin Yue Ao Shen Du He Zuo Qu) Co., Ltd. romanized; Beijing Jing Yi He Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/31New drug · Class 1 | GS3-007a干混悬剂 · No verified English nameCXHL2600135 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/01/30Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2600316 | Henan Run Hong Pharmaceutical Co., Ltd. romanized |
| 2026/01/30New drug · Class 3.1 | 清骨散颗粒 · No verified English nameCXZS2600007 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | CMG2349注射液 · No verified English nameCXSL2600156 | Chengdu En Mu Bio Technology Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2600155 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2600154 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | SG301注射液 · No verified English nameCXSL2600152 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | SYS6051 · No verified English nameCXSL2600151 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/01/30New drug · Class 1 | 注射用LY4170156 · No verified English nameCXSL2600149 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2026/01/30New drug · Class 2.4 | 注射用磷罗拉匹坦帕洛诺司琼 · No verified English nameCXHS2600019 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/01/30New drug · Class 2.4 | 氟[18F]妥司特注射液 · No verified English nameCXHL2600134 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
72 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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