YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 250 drug applications between 25 August 2021 and 31 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 23 drug names.
2021/08/25 – 2021/08/31
- New acceptances this week
- 250
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- Accepted this week, now under review
- 3
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
250filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 35 |
| New drug | 32 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| TCM | 66 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 5 |
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 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 2 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 3 | Acetylcysteine Granules | 2 | 1 | 4 |
| 4 | 吸入用七氟烷 · No verified English name | 2 | 1 | 0 |
| 5 | Ticagrelor Tablets | 2 | 1 | 10 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | Desvenlafaxine Extended-release Tablets | 2 | 1 | 0 |
| 8 | Milrinone Injection | 2 | 1 | 0 |
| 9 | Polidocanol Injection | 2 | 1 | 23 |
| 10 | Febuxostat Tablets | 2 | 1 | 12 |
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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 20 | 20 | 0 |
| 2 | Qin Huang Dao Da En Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 14 | 13 | 0 |
| 4 | Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Da Tong Wu Zhou Tong Pharmaceutical Co., Ltd. romanized | 7 | 3 | 0 |
| 6 | Merck Sharp & Dohme B.V. | 6 | 1 | 0 |
| 7 | Upjohn Manufacturing Ireland Unlimited | 6 | 1 | 0 |
| 8 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 5 | 2 | 5 |
| 9 | AstraZeneca Pharmaceuticals LP | 5 | 1 | 0 |
| 10 | Health Yuan Pharma Group Co., Ltd. romanized | 4 | 2 | 3 |
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
49 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/31Import · Class 1 | GSK3511294注射液 · No verified English nameJXSL2101107 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd |
| 2021/08/31Import · Class 1 | Etripamil 鼻喷雾剂 · No verified English nameJXHL2101171 | Milestone Pharmaceuticals Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2021/08/31Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2101026 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | IMM27M注射液 · No verified English nameCXSL2101298 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | 异体人源脂肪间充质干细胞注射液 · No verified English nameCXSL2101297 | Jiangsu De Kang Bio Technology Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101295 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | CM326注射液 · No verified English nameCXSL2101294 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | FCN-342片 · No verified English nameCXHL2101446 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | FCN-342片 · No verified English nameCXHL2101445 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | FCN-342片 · No verified English nameCXHL2101444 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | FCN-342片 · No verified English nameCXHL2101443 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101442 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101441 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/08/31New drug · Class 1 | LH-1802胶囊 · No verified English nameCXHL2101435 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2021/08/31New drug · Class 1 | LH-1802胶囊 · No verified English nameCXHL2101434 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2021/08/31New drug · Class 1 | LH-1802胶囊 · No verified English nameCXHL2101433 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2021/08/30Import · Class 1 | CG0070注射液 · No verified English nameJXSL2101105 | CG Oncology Inc.; Lepu Biopharma Co. Ltd. |
| 2021/08/30Generic · Class 3 | Milrinone InjectionCYHS2101658 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2021/08/30Generic · Class 3 | Milrinone InjectionCYHS2101657 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2021/08/30Generic · Class 3 | Prasugrel Hydrochloride TabletsCYHS2101653 | Chongqing Pharmaceuticals (Group) Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized |
| 2021/08/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2101642 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Di Kang Pharma Co., Ltd. romanized |
| 2021/08/30New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2101023 | Qilu Pharmaceutical Co., Ltd. |
| 2021/08/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2101293 | Jiangsu Kang Run Bio Technology Co., Ltd. romanized |
| 2021/08/30New drug · Class 3.2 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2101292 | Jiangsu Kang Run Bio Technology Co., Ltd. romanized |
| 2021/08/30New drug · Class 1 | 注射用CN202 · No verified English nameCXSL2101291 | Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/08/30New drug · Class 1 | PZ-1片 · No verified English nameCXHL2101440 | Chongqing Wen Li College romanized |
| 2021/08/30New drug · Class 1 | PZ-1片 · No verified English nameCXHL2101439 | Chongqing Wen Li College romanized |
| 2021/08/27Import · Class 1 | Rozanolixizumab注射液 · No verified English nameJXSL2101103 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd |
| 2021/08/27Import · Class 1 | HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101102 | Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/27Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2101652 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
19 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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