YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 216 drug applications between 16 May 2021 and 22 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 24 drug names.
2021/05/16 – 2021/05/22
- New acceptances this week
- 216
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
216filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 105 |
| New drug | 39 |
| Generic | 35 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 163 |
| Therapeutic biologic | 32 |
| TCM | 15 |
| 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普斯特片 · No verified English name | 4 | 2 | 0 |
| 2 | Propofol Medium And Long Chain Fat Emulsion Injection | 3 | 1 | 3 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Montelukast Sodium Chewable Tablets | 2 | 2 | 4 |
| 5 | Ambroxol Hydrochloride Injection | 2 | 2 | 9 |
| 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 | Tadalafil Tablets | 1 | 1 | 23 |
| 10 | Linagliptin Tablets | 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
147 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 6 | 4 | 0 |
| 2 | Xian Li Bang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 3 |
| 3 | Shandong Luo Xin Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 4 | N.V.Organon | 4 | 1 | 0 |
| 5 | Sichuan Bai Li Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 3 | 3 | 0 |
| 7 | Bayer AG | 3 | 2 | 0 |
| 8 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 3 | 2 | 3 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Amgen Europe B.V. | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/21Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101029 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/05/21Import · Class 1 | PB2452注射液 · No verified English nameJXSL2101028 | SFJ Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2021/05/21Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2101190 | Gui Lin Nan Yao Co., Ltd. romanized |
| 2021/05/21New drug · Class 1 | 注射用DN015089 · No verified English nameCXHL2101140 | Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/20Import · Class 1 | 泽弗利单抗注射液 · No verified English nameJXSL2101030 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/05/20Import · Class 1 | Capivasertib · No verified English nameJXHL2101051 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/20Import · Class 1 | Capivasertib · No verified English nameJXHL2101050 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/20Import · Class 2.4 | Selumetinib胶囊 · No verified English nameJXHL2101049 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2021/05/20Import · Class 2.4 | Selumetinib胶囊 · No verified English nameJXHL2101048 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2021/05/20Import · Class 2.4 | 达罗他胺片 · No verified English nameJXHL2101047 | Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd. |
| 2021/05/20Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101046 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/20Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101045 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/05/20New drug · Class 1.1 | 参远片 · No verified English nameCXZL2101010 | Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized |
| 2021/05/20New drug · Class 1 | HR17031注射液 · No verified English nameCXSL2101090 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101089 | Nanjing Xun Lu Medical Technology Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | 全人源抗CD19和CD22自体T细胞注射液 · No verified English nameCXSL2101088 | Nanjing Xun Lu Medical Technology Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101085 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/05/20New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHS2101017 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | 复方ACC007片 · No verified English nameCXHS2101016 | Jiangsu Ai Di Pharma Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | LDS片 · No verified English nameCXHL2101144 | Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | LDS片 · No verified English nameCXHL2101143 | Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | IMP5471-CA胶囊 · No verified English nameCXHL2101142 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2021/05/20New drug · Class 1 | IMP5471-CA胶囊 · No verified English nameCXHL2101141 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2021/05/19Import · Class 1 | BR55 · No verified English nameJXHL2101044 | Bracco International B.V.; Bracco Imaging Medical Technologies(Shanghai) Co. Ltd. |
| 2021/05/19Import · Class 2.4 | 注射用依拉环素 · No verified English nameJXHL2101043 | Everest Medicines (US) Limited; EverID Medicines (Beijing) Limited |
| 2021/05/19Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101179 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2101178 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | Leflunomide TabletsCYHS2101172 | Mei Luo Pharma Co., Ltd. romanized |
| 2021/05/19Generic · Class 3 | 聚普瑞锌颗粒? · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2101166 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2021/05/19New drug · Class 1 | PA3-17注射液 · No verified English nameCXSL2101087 | Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
38 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.