YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 121 drug applications between 6 September 2021 and 12 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 11 drug names.
2021/09/06 – 2021/09/12
- New acceptances this week
- 121
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
121filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 67 |
| New drug | 20 |
| Generic | 18 |
| Import | 8 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 64 |
| TCM | 38 |
| Therapeutic biologic | 16 |
| Prophylactic biologic | 3 |
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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carfilzomib For Injection | 3 | 1 | 0 |
| 2 | 烟酸缓释片 · No verified English name | 3 | 1 | 0 |
| 3 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 4 | Pramipexole Dihydrochloride Prolonged-release Tablets | 2 | 1 | 0 |
| 5 | Lincomycin Injection | 2 | 1 | 1 |
| 6 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
| 7 | 头孢地尼颗粒 · No verified English name | 1 | 1 | 3 |
| 8 | Levofloxacin Tablets | 1 | 1 | 7 |
| 9 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
| 10 | Oseltamivir Phosphate Capsules | 1 | 1 | 39 |
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
65 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 22 | 22 | 0 |
| 2 | Gansu Fu Ge Zang Yao Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Novartis Europharm Limited | 5 | 3 | 0 |
| 4 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 5 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 3 | 3 | 0 |
| 6 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 3 | 2 | 2 |
| 7 | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 3 | 1 | 3 |
| 9 | Sun Pharmaceutical Industries Limited | 2 | 2 | 0 |
| 10 | Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized | 2 | 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
32 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/08Import · Class 1 | TPX-0022胶囊 · No verified English nameJXHL2101175 | Turning Point Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/09/08New drug · Class 1 | XKH001注射液 · No verified English nameCXSL2101315 | Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | IBI397 · No verified English nameCXSL2101314 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/09/08New drug · Class 3.3 | 门冬胰岛素注射液 · No verified English nameCXSL2101313 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | LD002注射液 · No verified English nameCXSL2101312 | Zhejiang Lan Dun Pharma Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | 赛拉瑞韦钾片 · No verified English nameCXHS2101038 | Yin Xing Shu Pharma (Suzhou) Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized |
| 2021/09/08New drug · Class 2.4 | 示踪用盐酸米托蒽醌注射液 · No verified English nameCXHS2101037 | Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | DT678片 · No verified English nameCXHL2101462 | Beijing SL Pharmaceutical Co., Ltd. |
| 2021/09/08New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101461 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101460 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | PB-201片 · No verified English nameCXHL2101459 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | PB-201片 · No verified English nameCXHL2101458 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/09/08New drug · Class 1 | 硫酸舒欣啶注射液 · No verified English nameCXHL2101457 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2021/09/07Import · Class 1 | HP558注射液 · No verified English nameJXHL2101173 | Hinova Pharmaceuticals (USA) Inc.; Hinova Pharmaceuticals Inc. |
| 2021/09/07Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2101698 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2101697 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2101696 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Carfilzomib For InjectionCYHS2101695 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Carfilzomib For InjectionCYHS2101694 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Carfilzomib For InjectionCYHS2101693 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Lincomycin InjectionCYHS2101690 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Lincomycin InjectionCYHS2101689 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2021/09/07Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2101686 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/09/06Generic · Class 3 | 头孢地尼颗粒 · No verified English nameCYHS2101687 | Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized |
| 2021/09/06New drug · Class 1.3 | 马甲子叶 · No verified English nameCXZL2101026 | Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized |
| 2021/09/06New drug · Class 1.3 | 马甲子胶囊 · No verified English nameCXZL2101025 | Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized |
| 2021/09/06New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2101027 | Qilu Pharmaceutical Co., Ltd. |
| 2021/09/06New drug · Class 1 | 舒格利单抗注射液 · No verified English nameCXSS2101026 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2021/09/06New drug · Class 1 | 重组抗CD20人源化单克隆抗体注射液 · No verified English nameCXSL2101308 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/09/06New drug · Class 1 | ASC42片 · No verified English nameCXHL2101456 | Gan Lai Pharmaceutical 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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