YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 221 drug applications between 6 March 2021 and 12 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 18 drug names.
2021/03/06 – 2021/03/12
- New acceptances this week
- 221
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
221filings, 29 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 116 |
| New drug | 30 |
| Generic | 29 |
| Import re-registration | 18 |
| Import | 16 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| Therapeutic biologic | 35 |
| TCM | 23 |
| Prophylactic biologic | 7 |
| 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
18 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 | 盐酸溴己新颗粒 · No verified English name | 2 | 1 | 0 |
| 7 | Cinacalcet Hydrochloride Tablets | 2 | 1 | 2 |
| 8 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 9 | Tadalafil Tablets | 1 | 1 | 23 |
| 10 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
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
136 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 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Fresenius Kabi Austria GmbH | 7 | 2 | 0 |
| 4 | Gansu Qi Zheng Zang Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 7 | Santen Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 8 | Yue Kang Pharma Group Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | SANOFI PASTEUR | 3 | 2 | 0 |
| 10 | CISEN PHARMACEUTICAL CO., LTD. | 3 | 2 | 1 |
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
53 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/12Import · Class 1 | Berzosertib注射液 · No verified English nameJXHL2100087 | Merck Healthcare KGaA |
| 2021/03/12Generic · Class 3 | Amphotericin B Liposome for InjectionCYHS2101018 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/03/12Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2100278 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2021/03/12Generic · Class 3 | 盐酸溴己新颗粒 · No verified English nameCYHS2100274 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2021/03/12Generic · Class 3 | 盐酸溴己新颗粒 · No verified English nameCYHS2100273 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | AK104注射液 · No verified English nameCXSL2100095 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | AK109注射液 · No verified English nameCXSL2100094 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | AK112注射液 · No verified English nameCXSL2100093 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/12New drug · Class 2.2 | 康柏西普眼用注射液 · No verified English nameCXSL2100092 | Chengdu Kang Hong Bio Technology Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | REGEND001细胞自体回输制剂 · No verified English nameCXSL2100091 | Jiangxi Sheng Xian He Yi Xue Technology Co., Ltd. romanized |
| 2021/03/12New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSL2100090 | Hebei Da An Pharmaceutical Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | TNM002注射液 · No verified English nameCXSL2100089 | Zhuhai Tai Nuo Mai Bo Bio Technology Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | SHR3680片 · No verified English nameCXHL2100183 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | TT-00434片 · No verified English nameCXHL2100182 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | TT-00434片 · No verified English nameCXHL2100181 | Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized |
| 2021/03/12New drug · Class 1 | 注射用MT1002 · No verified English nameCXHL2100180 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 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 |
23 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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