YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 254 drug applications between 22 June 2021 and 28 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 24 drug names.
2021/06/22 – 2021/06/28
- New acceptances this week
- 254
- 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
254filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| New drug | 44 |
| Generic | 35 |
| Import | 26 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| Therapeutic biologic | 42 |
| TCM | 38 |
| 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pregabalin Capsules | 3 | 2 | 12 |
| 2 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 3 | Selexipag Tablets | 2 | 1 | 24 |
| 4 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
| 7 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 8 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 9 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 10 | Desmopressin Acetate Injection | 2 | 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
143 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 31 | 28 | 0 |
| 2 | Janssen Research & Development LLC | 8 | 3 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 4 | Baxalta US Inc. | 5 | 1 | 0 |
| 5 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | UCB Pharma S.A. | 4 | 1 | 0 |
| 8 | Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Xuan Zhu Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 3 | 2 | 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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/28Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2101051 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/06/28Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2101050 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/06/28Import · Class 1 | BI 1810631 片 · No verified English nameJXHL2101108 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/28Import · Class 1 | BI 1810631 片 · No verified English nameJXHL2101107 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/28Import · Class 1 | BI 1810631 片 · No verified English nameJXHL2101106 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/28Import · Class 1 | Linerixibat 片 · No verified English nameJXHL2101105 | GlaxoSmithKline(Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd |
| 2021/06/28Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2101347 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2021/06/28Generic · Class 3 | Ornidazole InjectionCYHS2101346 | Bei Da Pharmaceuticals Co., Ltd. romanized |
| 2021/06/28Generic · Class 3 | Ornidazole InjectionCYHS2101345 | Bei Da Pharmaceuticals Co., Ltd. romanized |
| 2021/06/28Generic · Class 3 | Fosaprepitant Dimeglumine for InjectionCYHS2101342 | Hunan Sai Long Pharma Co., Ltd. romanized |
| 2021/06/28Generic · Class 3 | 地塞米松眼用植入剂(用于泪小管) · No verified English nameCYHS2101341 | Beijing Nuo Kang Da Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Jin Yao Group Hebei Yong Guang Pharmaceutical Co., Ltd. romanized |
| 2021/06/28New drug · Class 1.1 | HC001颗粒 · No verified English nameCXZL2101015 | Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 2.2 | 三七总皂苷缓释胶囊 · No verified English nameCXZL2101014 | Jiang Zhong Pharma Co., Ltd. romanized |
| 2021/06/28New drug · Class 1.1 | 复方延麦搽剂 · No verified English nameCXZL2101013 | Shanghai Huo Er Bio Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | NBL-015注射液 · No verified English nameCXSL2101156 | Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | JS014注射液 · No verified English nameCXSL2101155 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 2.2 | 注射用伊尼妥单抗 · No verified English nameCXSL2101151 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | BEBT-109胶囊 · No verified English nameCXHL2101243 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | BEBT-109胶囊 · No verified English nameCXHL2101242 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 2.2 | 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHL2101241 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2021/06/28New drug · Class 2.2 | SBK003注射液 · No verified English nameCXHL2101240 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | BPI-23314片 · No verified English nameCXHL2101239 | Bei Da Pharma Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | BPI-23314片 · No verified English nameCXHL2101238 | Bei Da Pharma Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | TL938胶囊 · No verified English nameCXHL2101225 | Suzhou Tao Lve Bio Technology Co., Ltd. romanized |
| 2021/06/28New drug · Class 1 | TL938胶囊 · No verified English nameCXHL2101224 | Suzhou Tao Lve Bio Technology Co., Ltd. romanized |
| 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 |
49 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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