YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 128 drug applications between 16 April 2021 and 22 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 17, covering 12 drug names.
2021/04/16 – 2021/04/22
- New acceptances this week
- 128
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- 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
128filings, 17 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 57 |
| New drug | 27 |
| Generic | 17 |
| Import re-registration | 16 |
| Import | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 104 |
| Therapeutic biologic | 17 |
| TCM | 5 |
| Prophylactic biologic | 2 |
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
12 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 | Pregabalin Capsules | 2 | 1 | 12 |
| 3 | Ticagrelor Tablets | 2 | 1 | 10 |
| 4 | Cabozantinib Tablets | 2 | 1 | 0 |
| 5 | Doxofylline Injection | 1 | 1 | 5 |
| 6 | 布比卡因脂质体注射液 · No verified English name | 1 | 1 | 7 |
| 7 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 1 | 1 | 23 |
| 8 | Parecoxib Sodium for Injection | 1 | 1 | 2 |
| 9 | Regorafenib Tablets | 1 | 1 | 3 |
| 10 | Fluoxetine Hydrochloride Dispersible Tablets | 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
63 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 13 | 7 | 0 |
| 2 | Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 1 |
| 4 | Boehringer Ingelheim International GmbH | 6 | 2 | 0 |
| 5 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 7 | AstraZeneca AB | 4 | 1 | 0 |
| 8 | Lilly France | 4 | 1 | 0 |
| 9 | Yangtze River Pharmaceutical Group Co., Ltd | 3 | 3 | 1 |
| 10 | Hua Bei Pharmaceutical Hebei Hua Min Pharma 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
36 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/21Import · Class 3.1 | 曲妥珠单抗注射液(皮下注射) · No verified English nameJXSS2101004 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/04/21Import · Class 2.4 | Encorafenib硬胶囊 · No verified English nameJXHL2101010 | Pierre Fabre Medicament; Covance Pharmaceutical Research and Development(Beijing)Co. Ltd. |
| 2021/04/21Generic · Class 3 | Cabozantinib TabletsCYHS2101082 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/04/21Generic · Class 3 | Cabozantinib TabletsCYHS2101081 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | 注射用FDA018抗体偶联剂 · No verified English nameCXSL2101031 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/21New drug · Class 3.3 | CMAB820注射液 · No verified English nameCXSL2101030 | Shanghai Zhang Jiang Bio Technology Co., Ltd. romanized |
| 2021/04/21New drug · Class 3.3 | 重组抗VEGF人源化单克隆抗体Fab片段注射液 · No verified English nameCXSL2101029 | Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | LVGN7409单克隆抗体注射液 · No verified English nameCXSL2101028 | Li Jin Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101053 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101052 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | SR419胶囊 · No verified English nameCXHL2101051 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | SR419胶囊 · No verified English nameCXHL2101050 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | TQB3824片 · No verified English nameCXHL2101049 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/21New drug · Class 1 | TQB3824片 · No verified English nameCXHL2101048 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/21New drug · Class 1 | LNK01003片 · No verified English nameCXHL2101047 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/04/21New drug · Class 1 | LNK01003片 · No verified English nameCXHL2101046 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 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 |
6 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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