YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 266 drug applications between 31 August 2021 and 6 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 18 drug names.
2021/08/31 – 2021/09/06
- New acceptances this week
- 266
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
266filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| New drug | 42 |
| Generic | 26 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 134 |
| TCM | 96 |
| Therapeutic biologic | 35 |
| 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Atomoxetine Hydrochloride Oral Solution | 2 | 2 | 0 |
| 2 | Oseltamivir Phosphate Capsules | 2 | 2 | 39 |
| 3 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Pregabalin Capsules | 2 | 1 | 12 |
| 6 | Latamoxef Sodium for Injection | 2 | 1 | 1 |
| 7 | Pramipexole Dihydrochloride Prolonged-release Tablets | 2 | 1 | 0 |
| 8 | Febuxostat Tablets | 2 | 1 | 12 |
| 9 | Bromhexine Hydrochloride Solution For Inhalation | 1 | 1 | 1 |
| 10 | 头孢地尼颗粒 · No verified English name | 1 | 1 | 3 |
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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 39 | 39 | 0 |
| 2 | Qin Huang Dao Da En Pharma Co., Ltd. romanized | 29 | 29 | 0 |
| 3 | Gansu Fu Ge Zang Yao Co., Ltd. romanized | 16 | 16 | 0 |
| 4 | Dr. Falk Pharma GmbH | 8 | 3 | 0 |
| 5 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | AstraZeneca Pharmaceuticals LP | 5 | 1 | 0 |
| 7 | Novartis Europharm Limited | 4 | 2 | 0 |
| 8 | Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized | 3 | 2 | 1 |
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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/09/06New drug · Class 1 | ASC42片 · No verified English nameCXHL2101455 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/09/06New drug · Class 1 | TR64片 · No verified English nameCXHL2101450 | Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized |
| 2021/09/03New drug · Class 3.3 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101307 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101304 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101303 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/03New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101302 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/03New drug · Class 1 | TQB2916注射液 · No verified English nameCXSL2101299 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/09/03New drug · Class 2.2 | 小儿头孢呋辛酯干混悬剂(微球型) · No verified English nameCXHL2101454 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2021/09/02Import · Class 2.2 | Anifrolumab注射液 · No verified English nameJXSL2101106 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/09/02New drug · Class 3.3 | 利拉鲁肽注射液 · No verified English nameCXSS2101025 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2021/09/02New drug · Class 3.3 | 利拉鲁肽注射液 · No verified English nameCXSS2101024 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | TC-E202注射液 · No verified English nameCXSL2101306 | Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | K1注射液 · No verified English nameCXSL2101305 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2021/09/02New drug · Class 3.2 | 人凝血因子Ⅷ/血管性血友病因子复合物 · No verified English nameCXSL2101301 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2021/09/02New drug · Class 3.2 | 人凝血因子Ⅷ/血管性血友病因子复合物 · No verified English nameCXSL2101300 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2101296 | Shanghai Lai Fu Medical Technology Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | H018片 · No verified English nameCXHL2101453 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | HMPL-653胶囊 · No verified English nameCXHL2101452 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | HMPL-653胶囊 · No verified English nameCXHL2101451 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/09/02New drug · Class 1 | AB-106胶囊 · No verified English nameCXHL2101449 | Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2021/09/01Generic · Class 3 | Fudosteine oral solutionCYHS2101672 | Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/09/01Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2101669 | Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized |
| 2021/09/01Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2101668 | Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized |
21 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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