YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 261 drug applications between 26 May 2023 and 1 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 55 drug names.
2023/05/26 – 2023/06/01
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 4
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
261filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| Generic | 80 |
| New drug | 28 |
| Import | 19 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 45 |
| Therapeutic biologic | 26 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxacillin Sodium for Injection | 7 | 3 | 13 |
| 2 | Lactulose Oral Solution | 3 | 3 | 34 |
| 3 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 4 | Selexipag Tablets | 3 | 1 | 24 |
| 5 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 6 | Desvenlafaxine Extended-release Tablets | 3 | 1 | 0 |
| 7 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 8 | Famotidine Injection | 2 | 2 | 8 |
| 9 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 10 | Doxofylline Injection | 2 | 1 | 5 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Ping Guang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | AbbVie Inc. | 4 | 2 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 2 | 3 |
| 8 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 3 | 2 | 0 |
| 10 | Anhui Lei Yun Shang Pharma 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/01Import · Class 2.2 | 格菲妥单抗注射液 · No verified English nameJXSL2300101 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/06/01Import · Class 1 | Epcoritamab注射液 · No verified English nameJXSL2300100 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/06/01Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300134 | AbbVie Inc. |
| 2023/06/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301499 | Jiangsu Zhong Bang Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301498 | Jiangsu Zhong Bang Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Ebastine Oral SolutionCYHS2301495 | Hunan Jin Pu Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Milrinone InjectionCYHS2301494 | Zhejiang Ya Se Pharmaceuticals Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Milrinone InjectionCYHS2301493 | Zhejiang Ya Se Pharmaceuticals Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301488 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301487 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301485 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/06/01Generic · Class 3 | Brivaracetam Solution for InjectionCYHL2300072 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/06/01New drug · Class 1 | 注射用SG1827 · No verified English nameCXSL2300387 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | 盐酸希美替尼片 · No verified English nameCXHL2300588 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | HSK34890片 · No verified English nameCXHL2300587 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | HSK34890片 · No verified English nameCXHL2300586 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | TQ-B3234胶囊 · No verified English nameCXHL2300585 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | TQ-B3234胶囊 · No verified English nameCXHL2300584 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2023/06/01New drug · Class 1 | TQ-B3234胶囊 · No verified English nameCXHL2300583 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2023/05/31Import · Class 1 | PF-06823859注射液 · No verified English nameJXSL2300099 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/05/31Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301483 | Nanjing Kang Chuan Ji Pharmaceuticals Technology Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2023/05/31Generic · Class 3 | Diprophylline InjectionCYHS2301480 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2301475 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2301474 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2301473 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Peramivir InjectionCYHS2301470 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Salbutamol Sulfate injectionCYHS2301469 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301467 | Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301466 | Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/31Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301465 | Name not romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
53 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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