YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 175 drug applications between 27 September 2021 and 3 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 23 drug names.
2021/09/27 – 2021/10/03
- New acceptances this week
- 175
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- 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
175filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 78 |
| New drug | 34 |
| Generic | 33 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 141 |
| TCM | 18 |
| Therapeutic biologic | 15 |
| 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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lacosamide Oral Solution | 2 | 2 | 0 |
| 2 | Voriconazole for Injection | 2 | 2 | 5 |
| 3 | Linezolid and Glucose Injection | 2 | 1 | 3 |
| 4 | Topiroxostat Tablets | 2 | 1 | 0 |
| 5 | Torsemide Injection | 2 | 1 | 1 |
| 6 | Lacosamide Tablets | 2 | 1 | 0 |
| 7 | Losartan Potassium Tablets | 2 | 1 | 5 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 10 | Butorphanol Tartrate 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
106 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 2 | Shenzhen Ke Xing Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Bayer AG | 5 | 1 | 0 |
| 5 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Hubei Min Kang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Jiangxi Di Kang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Hebei Wu Luo Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Shanghai Qiang Sheng Pharmaceutical Co., Ltd. romanized | 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
60 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/30Import · Class 3.1 | 甘精胰岛素利司那肽注射液2:1 · No verified English nameJXSS2101025 | Sanofi-Aventis Groupe; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2021/09/30New drug · Class 1 | 盐酸柯诺拉赞片 · No verified English nameCXHS2101047 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | 盐酸柯诺拉赞片 · No verified English nameCXHS2101046 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | 培化西海马肽注射液 · No verified English nameCXHS2101045 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | 培化西海马肽注射液 · No verified English nameCXHS2101044 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | 培化西海马肽注射液 · No verified English nameCXHS2101043 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101537 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101536 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101535 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | OB756片 · No verified English nameCXHL2101534 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | IPG7236片 · No verified English nameCXHL2101533 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | IPG7236片 · No verified English nameCXHL2101532 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/30New drug · Class 2.2 | 注射用盐酸特拉唑嗪 · No verified English nameCXHL2101531 | Bang En Tai (Xiamen) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101521 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101520 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | SDT-102 片 · No verified English nameCXHL2101517 | Suzhou Jin Sheng Pharma Co., Ltd. romanized |
| 2021/09/30New drug · Class 1 | SDT-102 片 · No verified English nameCXHL2101516 | Suzhou Jin Sheng Pharma Co., Ltd. romanized |
| 2021/09/29Import · Class 3.1 | 甘精胰岛素利司那肽注射液1:1 · No verified English nameJXSS2101024 | Sanofi K. K.; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2021/09/29Import · Class 1 | TJ271 注射液 · No verified English nameJXSL2101114 | I-MAB Biopharma US Limited; I-MAB Biopharm Co. Ltd |
| 2021/09/29Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2101113 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/09/29Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2101112 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/09/29Import · Class 1 | Paxalisib 胶囊 · No verified English nameJXHL2101194 | KAZIA THERAPEUTICS LIMITED; Jiangsu Simcere Pharmaceutical Co. Ltd. |
| 2021/09/29Import · Class 1 | ONC201胶囊 · No verified English nameJXHL2101193 | Sanjiu Healthy World Company Limited; China Resources Sanjiu Medical&Pharmaceutical Co. Ltd. |
| 2021/09/29Import · Class 1 | AM006 · No verified English nameJXHL2101192 | Affamed Therapeutics (US) Inc. |
| 2021/09/29Import · Class 1 | Avacopan硬胶囊 · No verified English nameJXHL2101190 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101189 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101188 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101187 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Generic · Class 3 | Torsemide InjectionCYHS2101800 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Torsemide InjectionCYHS2101799 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
30 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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