YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 416 drug applications between 30 January 2026 and 5 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 54 drug names.
2026/01/30 – 2026/02/05
- New acceptances this week
- 416
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 115
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
416filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 236 |
| Generic | 78 |
| New drug | 62 |
| Unspecified | 16 |
| Import re-registration | 16 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 149 |
| Therapeutic biologic | 45 |
| Biologic | 8 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Cyclophosphamide Injection | 3 | 1 | 6 |
| 3 | 莫立司他钠片 · No verified English name | 3 | 1 | 0 |
| 4 | Ibuprofen Suspension | 2 | 2 | 14 |
| 5 | 氧 · No verified English name | 2 | 2 | 15 |
| 6 | Dapagliflozin Tablets | 2 | 2 | 84 |
| 7 | Fluticasone Propionate Cream | 2 | 1 | 12 |
| 8 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 60 | 46 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 16 | 8 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bayer AG | 6 | 2 | 0 |
| 6 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Jiangxi Wang Shi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/05Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2600381 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | 盐酸溴己新吸入溶液 · No verified English nameCYHS2600380 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | 盐酸溴己新吸入溶液 · No verified English nameCYHS2600379 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600376 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600375 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600374 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Ferrous Succinate TabletsCYHS2600370 | Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 1.1 | 双鱼颗粒 · No verified English nameCXZS2600012 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 3.1 | 一贯煎颗粒 · No verified English nameCXZS2600011 | Jiu Zhi Tang Co., Ltd. romanized |
| 2026/02/05New drug · Class 1.1 | 清润养目颗粒 · No verified English nameCXZL2600021 | Shanghai Pharmaceuticals Group Zhong Yao Research Institute Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | 9MW2821 · No verified English nameCXSL2600177 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | CVL006注射液 · No verified English nameCXSL2600176 | Fu Kang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/02/05New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600175 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/02/05New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600174 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/02/05New drug · Class 3.3 | LPS-001片 · No verified English nameCXSL2600173 | Le Pu Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 3.3 | LPS-001片 · No verified English nameCXSL2600172 | Le Pu Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 3.3 | LPS-001片 · No verified English nameCXSL2600171 | Le Pu Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | IVB107 注射液 · No verified English nameCXSL2600170 | Beijing Nuo Wei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2600169 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2600168 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600151 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600150 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600149 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600148 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600147 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | HS-20136注射液 · No verified English nameCXHL2600146 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/05New drug · Class 1 | INS018_055B雾化吸入剂 · No verified English nameCXHL2600145 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Bifonazole SolutionCYHS2600356 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2600354 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600353 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
66 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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