YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 186 drug applications between 14 April 2021 and 20 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 17 drug names.
2021/04/14 – 2021/04/20
- New acceptances this week
- 186
- 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
186filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 23 |
| New drug | 22 |
| Import re-registration | 12 |
| Import | 10 |
| Unspecified | 3 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 162 |
| Therapeutic biologic | 15 |
| TCM | 5 |
| Prophylactic biologic | 3 |
| 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 | Afatinib Dimaleate Tablets | 3 | 2 | 2 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | Lacosamide Tablets | 2 | 1 | 0 |
| 4 | Pregabalin Capsules | 2 | 1 | 12 |
| 5 | Desloratadine Tablets | 1 | 1 | 0 |
| 6 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 7 | Levofloxacin and Sodium Chloride Injection | 1 | 1 | 14 |
| 8 | 布比卡因脂质体注射液 · No verified English name | 1 | 1 | 7 |
| 9 | Dutasteride Soft Capsules | 1 | 1 | 0 |
| 10 | Leflunomide 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
78 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 53 | 25 | 0 |
| 2 | Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 6 | 2 | 0 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 1 |
| 7 | Yangtze River Pharmaceutical Group Co., Ltd | 3 | 3 | 1 |
| 8 | Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | 3 | 1 | 3 |
| 10 | Hangzhou Mo Sha Dong Pharmaceutical Co., Ltd. romanized | 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
32 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/19Import · Class 1 | BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101011 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/04/19Import · Class 1 | BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2101011 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/04/19Import · Class 2.2; 2.4 | 盐酸二甲双胍迟释片 · No verified English nameJXHL2101009 | Anji Pharma (US) LLC; Anji Pharma (Shanghai) Limited |
| 2021/04/19New drug · Class 1 | BR101注射液 · No verified English nameCXSL2101026 | Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/04/19New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101045 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/19New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101044 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/19New drug · Class 1 | ICP-033片 · No verified English nameCXHL2101043 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/19New drug · Class 1 | ICP-033片 · No verified English nameCXHL2101042 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/19New drug · Class 1 | TQB3820片 · No verified English nameCXHL2101040 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/19New drug · Class 1 | TQB3820片 · No verified English nameCXHL2101039 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/16Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101069 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2021/04/16Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2101068 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/16New drug · Class 1.1 | 芪连降糖片 · No verified English nameCXZL2101006 | Shou Du Yi Ke University Fu Shu Beijing Shi Ji Tan Hospital romanized |
| 2021/04/16New drug · Class 2.3 | 散风通窍滴丸 · No verified English nameCXZL2101005 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/16New drug · Class 1 | GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2101024 | Shanghai Ji Bei Bio Technology Co., Ltd. romanized |
| 2021/04/16New drug · Class 1 | YR-1702注射液 · No verified English nameCXHL2101038 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/16New drug · Class 2.4 | HR19034滴眼液 · No verified English nameCXHL2101037 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/04/16New drug · Class 2.4 | HR19034滴眼液 · No verified English nameCXHL2101036 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/04/16New drug · Class 2.2 | 巯嘌呤咀嚼片 · No verified English nameCXHL2101035 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/04/16New drug · Class 2.4 | Chidamide TabletsCXHL2100224 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/04/15New drug · Class 1 | UB-421注射液 · No verified English nameCXSL2101027 | Lian Yao (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/04/15New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101025 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/15New drug · Class 1 | 注射用HRS3658 · No verified English nameCXHL2101034 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/04/15New drug · Class 1 | 赛沃替尼片 · No verified English nameCXHL2101033 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/04/15New drug · Class 1 | 赛沃替尼片 · No verified English nameCXHL2101032 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/04/15New drug · Class 2.3 | 阿利沙坦酯吲达帕胺缓释片 · No verified English nameCXHL2101031 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2021/04/14Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101010 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101009 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2101008 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/04/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2101059 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
2 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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