YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 172 drug applications between 5 March 2021 and 11 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 14 drug names.
2021/03/05 – 2021/03/11
- New acceptances this week
- 172
- Drugs with new generic filings (by drug name, de-duplicated)
- 14
- 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
172filings, 24 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| Generic | 24 |
| New drug | 22 |
| Import | 17 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 113 |
| Therapeutic biologic | 31 |
| TCM | 22 |
| Prophylactic biologic | 3 |
| 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
14 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Enzalutamide Soft Capsules | 3 | 3 | 2 |
| 2 | 二甲磺酸赖右苯丙胺胶囊 · No verified English name | 3 | 1 | 0 |
| 3 | Levetiracetam in Sodium Chloride Injection | 3 | 1 | 2 |
| 4 | Levofloxacin Injection | 2 | 1 | 1 |
| 5 | Levofloxacin Tablets | 2 | 1 | 7 |
| 6 | Atomoxetine Hydrochloride Capsules | 2 | 1 | 6 |
| 7 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 8 | Tadalafil Tablets | 1 | 1 | 23 |
| 9 | Tofacitinib Citrate Tablets | 1 | 1 | 1 |
| 10 | Parecoxib Sodium for Injection | 1 | 1 | 2 |
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
100 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized | 8 | 5 | 0 |
| 2 | Fresenius Kabi Austria GmbH | 7 | 2 | 0 |
| 3 | Gansu Qi Zheng Zang Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 5 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Chiesi Farmaceutici S.p.A. | 3 | 3 | 0 |
| 8 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 3 | 2 | 0 |
| 9 | CISEN PHARMACEUTICAL CO., LTD. | 3 | 2 | 1 |
| 10 | Sanofi-Aventis Deutschland GmbH | 3 | 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
46 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/11Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2100041 | Merck Sharp & Dohme Corp. |
| 2021/03/11Import · Class 1 | KSI-301注射液 · No verified English nameJXSL2100040 | Kodiak Sciences China Inc. |
| 2021/03/11Import · Class 1 | KSI-301注射液 · No verified English nameJXSL2100039 | Kodiak Sciences China Inc. |
| 2021/03/11Import · Class 1 | IMSA101注射液 · No verified English nameJXHL2100084 | ImmuneSensor Therapeutics Inc. |
| 2021/03/11New drug · Class 1 | TT-01025-CL片 · No verified English nameCXHL2100176 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/11New drug · Class 1 | TT-01025-CL片 · No verified English nameCXHL2100175 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/11New drug · Class 1 | ASC40片 · No verified English nameCXHL2100174 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/03/11New drug · Class 1 | ASC40片 · No verified English nameCXHL2100173 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/03/11New drug · Class 1 | ASC40片 · No verified English nameCXHL2100172 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/03/10Import · Class 1 | MK-7684A注射液 · No verified English nameJXSL2101001 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/03/10Import · Class 1 | MK-7684A注射液 · No verified English nameJXSL2101000 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/03/10Import · Class 1 | PF-07256472 · No verified English nameJXSL2100038 | Pfizer Inc. |
| 2021/03/10Import · Class 1 | Xevinapant口服溶液 · No verified English nameJXHL2100083 | Debiopharm International SA |
| 2021/03/10Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2100271 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/03/10Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2100270 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/03/10Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2100269 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/03/10Generic · Class 3 | 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100016 | Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized |
| 2021/03/10Generic · Class 3 | 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100015 | Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized |
| 2021/03/10Generic · Class 3 | 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100014 | Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized |
| 2021/03/10New drug · Class 1.1 | 苏夏解郁除烦胶囊 · No verified English nameCXZS2100007 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | SHR-1905注射液 · No verified English nameCXSL2100088 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | 重组柯萨奇病毒B3注射剂 · No verified English nameCXSL2100087 | Wuhan Bo Wei De Bio Technology Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | TT-00420片 · No verified English nameCXHL2100179 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | TT-00420片 · No verified English nameCXHL2100178 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | TT-00420片 · No verified English nameCXHL2100177 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/10New drug · Class 1 | SYHA1811片 · No verified English nameCXHL2100171 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100264 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2021/03/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100263 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2021/03/09New drug · Class 2.2 | 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100086 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/03/09New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2100085 | Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized |
16 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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