YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 220 drug applications between 20 May 2021 and 26 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 27 drug names.
2021/05/20 – 2021/05/26
- New acceptances this week
- 220
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
220filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 121 |
| Generic | 35 |
| New drug | 27 |
| Import | 24 |
| Import re-registration | 9 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 180 |
| Therapeutic biologic | 30 |
| TCM | 8 |
| Biologic | 1 |
| Prophylactic biologic | 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Escitalopram Oxalate Tablets | 3 | 1 | 6 |
| 2 | Olanzapine Orally Disintegrating Tablets | 2 | 1 | 0 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Potassium Chloride Granules | 2 | 1 | 4 |
| 5 | Metoprolol Succinate Sustained-release Tablets | 2 | 1 | 4 |
| 6 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 7 | Atorvastatin Calcium Tablets | 2 | 1 | 24 |
| 8 | Sodium Valproate Concentrated Solution for Injection | 1 | 1 | 0 |
| 9 | Ezetimibe Tablets | 1 | 1 | 4 |
| 10 | 依折麦布瑞舒伐他汀钙片(III) · No verified English name | 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
118 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 13 | 13 | 0 |
| 2 | Merck Sharp & Dohme B.V. | 10 | 2 | 0 |
| 3 | AstraZeneca AB | 6 | 4 | 0 |
| 4 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 6 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 8 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | YaoPharma Co., Ltd. | 4 | 2 | 0 |
| 10 | N.V.Organon | 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
58 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/26Import · Class 1 | BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101034 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/05/26Import · Class 2.4 | INC280 · No verified English nameJXHL2101058 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/26Import · Class 2.4 | INC280 · No verified English nameJXHL2101057 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/26Import · Class 2.4 | Ponatinib TabletsJXHL2101056 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Import · Class 2.4 | Ponatinib TabletsJXHL2101055 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Import · Class 2.4 | Ponatinib TabletsJXHL2101054 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Import · Class 2.4 | 泊那替尼胶囊 · No verified English nameJXHL2101053 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Import · Class 2.4 | 泊那替尼胶囊 · No verified English nameJXHL2101052 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Generic · Class 3 | Ornidazole InjectionCYHS2101202 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | Ornidazole InjectionCYHS2101201 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | Levofloxacin InjectionCYHS2101196 | Tai Zhou Zhen He Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | Chloral Hydrate SuppositoriesCYHL2101012 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(III) · No verified English nameCYHL2101011 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(II) · No verified English nameCYHL2101010 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2021/05/26Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(I) · No verified English nameCYHL2101009 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2021/05/26New drug · Class 1 | AK109注射液 · No verified English nameCXSL2101093 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2021/05/26New drug · Class 1 | 注射用HRS9432 · No verified English nameCXHL2101157 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/05/26New drug · Class 1 | GFH925片 · No verified English nameCXHL2101156 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2021/05/26New drug · Class 1 | GFH925片 · No verified English nameCXHL2101155 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2021/05/25Generic · Class 3 | Potassium Chloride GranulesCYHS2101210 | Hua Nuo Pharmaceuticals (Guangzhou) Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2021/05/25Generic · Class 3 | Potassium Chloride GranulesCYHS2101209 | Hua Nuo Pharmaceuticals (Guangzhou) Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2021/05/25Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101206 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/05/25New drug · Class 3.4 | 乙型肝炎人免疫球蛋白 · No verified English nameCXSS2101003 | Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized |
| 2021/05/25New drug · Class 1 | TNM001注射液 · No verified English nameCXSL2101096 | Zhuhai Tai Nuo Mai Bo Bio Technology Co., Ltd. romanized |
| 2021/05/25New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101145 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/05/24Import · Class 3.1 | Fremanezumab注射液 · No verified English nameJXSL2101031 | TEVA GmbH; Teva Pharmaceutical Information Consulting (Shanghai) Co. Ltd. |
| 2021/05/24Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101195 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/05/24New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101092 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/05/24New drug · Class 1 | BGB-15025胶囊 · No verified English nameCXHL2101152 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/05/24New drug · Class 1 | BGB-15025胶囊 · No verified English nameCXHL2101151 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
28 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.