YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 252 drug applications between 25 May 2023 and 31 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 50 drug names.
2023/05/25 – 2023/05/31
- New acceptances this week
- 252
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
252filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 122 |
| Generic | 70 |
| New drug | 25 |
| Import | 18 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 174 |
| TCM | 46 |
| Therapeutic biologic | 28 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxacillin Sodium for Injection | 5 | 2 | 13 |
| 2 | Roxadustat Capsules | 4 | 2 | 17 |
| 3 | Selexipag Tablets | 3 | 1 | 24 |
| 4 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 5 | Desvenlafaxine Extended-release Tablets | 3 | 1 | 0 |
| 6 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 7 | Famotidine Injection | 2 | 2 | 8 |
| 8 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 9 | Doxofylline Injection | 2 | 1 | 5 |
| 10 | Ropinirole Hydrochloride Sustained-release Tablets | 2 | 1 | 2 |
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
171 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 6 | 1 | 0 |
| 2 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Pfizer Inc. | 5 | 3 | 0 |
| 5 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | AstraZeneca AB | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/05/31Generic · Class 3 | Famotidine InjectionCYHS2301461 | Ji Chuan Pharma Group Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/05/31New drug · Class 1 | Obexelimab注射液 · No verified English nameCXSL2300386 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2023/05/31New drug · Class 1 | RY_SW01细胞注射液 · No verified English nameCXSL2300385 | Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized |
| 2023/05/31New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300384 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/31New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300383 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/31New drug · Class 1 | ZT002注射液 · No verified English nameCXSL2300382 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/31New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2300381 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/30Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2300040 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/05/30Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300133 | AbbVie Inc. |
| 2023/05/30Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300132 | AbbVie Inc. |
| 2023/05/30Generic · Class 3 | Furosemide InjectionCYHS2301453 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301452 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301451 | Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301449 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301448 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2301447 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Magnesium Sulfate InjectionCYHS2301445 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 去氧肾上腺素酮咯酸溶液 · No verified English nameCYHS2301443 | Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30New drug · Class 1 | QL1706H注射液 · No verified English nameCXSL2300380 | Qilu Pharmaceutical Co., Ltd. |
41 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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