YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 230 drug applications between 26 February 2021 and 4 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 22, covering 17 drug names.
2021/02/26 – 2021/03/04
- New acceptances this week
- 230
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- Accepted this week, now under review
- 0
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
230filings, 22 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 102 |
| New drug | 50 |
| Import | 27 |
| Generic | 22 |
| Unspecified | 19 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| Therapeutic biologic | 34 |
| TCM | 9 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Apremilast Tablets | 3 | 1 | 0 |
| 2 | Dexmedetomidine Hydrochloride Injection | 2 | 2 | 0 |
| 3 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 4 | Memantine Hydrochloride Tablets | 2 | 1 | 2 |
| 5 | Compound Ipratropium Bromide Solution For Inhalation | 1 | 1 | 4 |
| 6 | Cefdinir Capsules | 1 | 1 | 0 |
| 7 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 1 | 1 | 2 |
| 8 | 注射用奥美拉唑钠(静脉滴注) · No verified English name | 1 | 1 | 0 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 1 | 1 | 10 |
| 10 | Moxifloxacin Hydrochloride Eye Drops | 1 | 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
130 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Bayer Inc. | 6 | 1 | 0 |
| 4 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Aligos Therapeutics Inc. | 4 | 2 | 0 |
| 8 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Qilu Pharmaceutical (Hainan) Co., Ltd | 4 | 2 | 0 |
| 10 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized | 4 | 1 | 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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/04Import · Class 1 | CG0070注射液 · No verified English nameJXSL2100029 | CG Oncology Inc. |
| 2021/03/04Import · Class 1 | MB-102注射液 · No verified English nameJXHL2100079 | MediBeacon Inc. |
| 2021/03/04Import · Class 1 | ALG-010133注射液 · No verified English nameJXHL2100075 | Aligos Therapeutics Inc. |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊 · No verified English nameJXHL2100074 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊 · No verified English nameJXHL2100073 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2100072 | Karyopharm Therapeutics Inc. |
| 2021/03/04Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100071 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100070 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | 注射用LY3437943 · No verified English nameJXHL2100069 | Eli Lilly and Company |
| 2021/03/04Generic · Class 3 | Carbocisteine Oral SolutionCYHS2100254 | Guangdong Pin Cheng Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2021/03/04Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2100252 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | AK104注射液 · No verified English nameCXSL2100082 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | IBI321 · No verified English nameCXSL2100081 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100009 | Bei Da Pharma Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2100008 | Bei Da Pharma Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | YY-20394片 · No verified English nameCXHL2100169 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100168 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100167 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100166 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100165 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100164 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100163 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100162 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | GW117胶囊 · No verified English nameCXHL2100161 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | SHR0302片 · No verified English nameCXHL2100160 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/03/04New drug · Class 1 | SHR0302片 · No verified English nameCXHL2100159 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/03/03Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2100068 | AstraZeneca AB |
| 2021/03/03Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2100067 | AstraZeneca AB |
| 2021/03/03Generic · Class 3 | Apremilast TabletsCYHS2101013 | Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized |
| 2021/03/03Generic · Class 3 | Apremilast TabletsCYHS2101012 | Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized |
49 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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