YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 211 drug applications between 19 June 2021 and 25 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 28, covering 17 drug names.
2021/06/19 – 2021/06/25
- New acceptances this week
- 211
- 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
211filings, 28 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 111 |
| New drug | 36 |
| Import | 29 |
| Generic | 28 |
| Unspecified | 4 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| Therapeutic biologic | 40 |
| TCM | 14 |
| 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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Celecoxib Capsules | 4 | 1 | 5 |
| 2 | Pregabalin Capsules | 3 | 2 | 12 |
| 3 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 4 | Selexipag Tablets | 2 | 1 | 24 |
| 5 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 6 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
| 7 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 8 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 9 | Itraconazole Oral Solution | 1 | 1 | 1 |
| 10 | Warfarin Sodium Tablets | 1 | 1 | 1 |
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
128 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 2 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 4 | Baxalta US Inc. | 5 | 1 | 0 |
| 5 | IPSEN PHARMA | 5 | 1 | 0 |
| 6 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | UCB Pharma S.A. | 4 | 1 | 0 |
| 8 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 4 | 1 | 4 |
| 9 | Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Xuan Zhu Bio Technology 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/25Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101012 | Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd |
| 2021/06/25Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101011 | Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd |
| 2021/06/25Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101010 | Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd |
| 2021/06/25Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101009 | Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd |
| 2021/06/25Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSS2101008 | Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd |
| 2021/06/25Import · Class 1 | SAR439459注射用粉针 · No verified English nameJXSL2101049 | sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd. |
| 2021/06/25Import · Class 1 | RO7112689 · No verified English nameJXSL2101048 | F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2021/06/25Import · Class 1 | Zenocutuzumab注射液 · No verified English nameJXSL2101046 | Merus N.V.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/06/25Import · Class 1 | Relatlimab注射液 · No verified English nameJXSL2101045 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2021/06/25Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2101104 | Eisai Europe Ltd. |
| 2021/06/25Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2101103 | Eisai Europe Ltd. |
| 2021/06/25Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2101102 | Eisai Europe Ltd. |
| 2021/06/25Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2101101 | Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd. |
| 2021/06/25Import · Class 2.2 | 盐酸毛果芸香碱微量眼用溶液 · No verified English nameJXHL2101100 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd |
| 2021/06/25Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2101349 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2021/06/25Generic · Class 3 | Warfarin Sodium TabletsCYHS2101348 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/06/25Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101332 | Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2021/06/25Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2101321 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2021/06/25Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2101320 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101154 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101147 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2101146 | Shanghai Hui Cun Medical Technology Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | 注射用IMM01 · No verified English nameCXSL2101143 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | TQB3617胶囊 · No verified English nameCXHL2101237 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/06/25New drug · Class 1 | TQB3617胶囊 · No verified English nameCXHL2101236 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/06/25New drug · Class 1 | SPH6516片 · No verified English nameCXHL2101235 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | SPH6516片 · No verified English nameCXHL2101234 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | ADC189片 · No verified English nameCXHL2101233 | An Di Kang (Wuxi) Bio Technology Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101232 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/06/25New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101231 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
40 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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