YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 214 drug applications between 25 February 2021 and 3 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 17 drug names.
2021/02/25 – 2021/03/03
- New acceptances this week
- 214
- 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
214filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| New drug | 44 |
| Import | 29 |
| Unspecified | 22 |
| Generic | 20 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| Therapeutic biologic | 34 |
| TCM | 5 |
| Biologic | 4 |
| Prophylactic 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
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 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 3 | Dantrolene Sodium Capsules | 1 | 1 | 0 |
| 4 | Compound Ipratropium Bromide Solution For Inhalation | 1 | 1 | 4 |
| 5 | Palbociclib Capsules | 1 | 1 | 0 |
| 6 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 1 | 1 | 2 |
| 7 | 孟鲁司特钠颗粒 · No verified English name | 1 | 1 | 0 |
| 8 | Levofloxacin Tablets | 1 | 1 | 7 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 1 | 1 | 10 |
| 10 | Dexmedetomidine Hydrochloride Injection | 1 | 1 | 0 |
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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 7 | 2 | 0 |
| 2 | Bayer Inc. | 6 | 1 | 0 |
| 3 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Qilu Pharmaceutical (Hainan) Co., Ltd | 4 | 2 | 0 |
| 7 | Fertin Pharma A/S | 4 | 1 | 0 |
| 8 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 9 | Novo Nordisk A/S | 4 | 1 | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/03/03Generic · Class 3 | Apremilast TabletsCYHS2101011 | Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized |
| 2021/03/03New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2101001 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2021/03/03New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2100080 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/03New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2100079 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/03New drug · Class 1 | 3D-229注射液 · No verified English nameCXSL2100078 | Xu Zhou Si Lu Di Pharma Co., Ltd. romanized |
| 2021/03/03New drug · Class 2.1 | HECB1701301长效肌肉注射剂 · No verified English nameCXHL2101002 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/03/03New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100154 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/03New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100153 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/03New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100152 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/02Import · Class 1 | AM006 · No verified English nameJXHL2100066 | Affamed Therapeutics (HK) Limited |
| 2021/03/02Import · Class 1 | AM006 · No verified English nameJXHL2100065 | Affamed Therapeutics (HK) Limited |
| 2021/03/02Generic · Class 3 | Metformin Hydrochloride Extended-release TabletsCYHS2100248 | Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/03/02Generic · Class 3 | 米诺地尔酊 · No verified English nameCYHS2100246 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2021/03/02Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2100245 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/03/02New drug · Class 3.2 | 注射用人干扰素γ · No verified English nameCXSS2100029 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/02New drug · Class 3.2 | 注射用人干扰素γ · No verified English nameCXSS2100028 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/02New drug · Class 2.2 | 注射用人干扰素γ · No verified English nameCXSS2100027 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/02New drug · Class 2.2 | 注射用人干扰素γ · No verified English nameCXSS2100026 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/02New drug · Class 1 | 血浆生物净化柱 · No verified English nameCXSL2100077 | Shanghai Wei Zhi Zhuo Bio Technology Co., Ltd. romanized |
| 2021/03/02New drug · Class 2.4 | Roxadustat CapsulesCXHL2100151 | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/03/02New drug · Class 2.4 | Roxadustat CapsulesCXHL2100150 | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/03/02New drug · Class 2.4 | Irinotecan Liposome injectionCXHL2100149 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/03/01Generic · Class 3 | Olmesartan Medoxomil and Amlodipine Besylate TabletsCYHS2101010 | Jilin Sheng De Shang Pharma Co., Ltd. romanized |
| 2021/02/27Import · Class 1 | 注射用E6201 · No verified English nameJXHL2100064 | JS INNOPHARM LIMITED |
| 2021/02/27Generic · Class 3 | Fudosteine oral solutionCYHS2100241 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/02/27New drug · Class 3.3 | LY01015注射液 · No verified English nameCXSL2100076 | Shandong Bo An Bio Technology Co., Ltd. romanized |
43 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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