YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 277 drug applications between 27 May 2023 and 2 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 55 drug names.
2023/05/27 – 2023/06/02
- New acceptances this week
- 277
- 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
277filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 127 |
| Generic | 86 |
| New drug | 35 |
| Import | 20 |
| Unspecified | 6 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 212 |
| TCM | 35 |
| Therapeutic biologic | 30 |
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 | 4 | 4 | 34 |
| 3 | Doxofylline Injection | 3 | 2 | 5 |
| 4 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 5 | Selexipag Tablets | 3 | 1 | 24 |
| 6 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 7 | Desvenlafaxine Extended-release Tablets | 3 | 1 | 0 |
| 8 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 9 | Peramivir Injection | 2 | 2 | 7 |
| 10 | Famotidine Injection | 2 | 2 | 8 |
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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | AbbVie Inc. | 4 | 2 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 2 | 3 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Anhui Pioneer Pharmaceutical Co., Ltd | 3 | 3 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/02Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2300136 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/06/02Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2300135 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/06/02Generic · Class 3 | Potassium Citrate Extendedrelease TabletsCYHS2301506 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/02Generic · Class 3 | Potassium Citrate Extendedrelease TabletsCYHS2301505 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/02Generic · Class 3 | Peramivir InjectionCYHS2301504 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/06/02Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2301503 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/06/02Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHL2300074 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液 · No verified English nameCXSS2300043 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液 · No verified English nameCXSS2300042 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液 · No verified English nameCXSS2300041 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液 · No verified English nameCXSS2300040 | Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300389 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | BGB-A445注射液 · No verified English nameCXSL2300388 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | HRS-6209片 · No verified English nameCXHL2300596 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | HRS-6209片 · No verified English nameCXHL2300595 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | BGB-15025片 · No verified English nameCXHL2300594 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | BGB-15025片 · No verified English nameCXHL2300593 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 苹果酸司曲替尼胶囊 · No verified English nameCXHL2300592 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | 苹果酸司曲替尼胶囊 · No verified English nameCXHL2300591 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | JK0564片 · No verified English nameCXHL2300590 | Tianjin Ji Kun Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/02New drug · Class 1 | JK0564片 · No verified English nameCXHL2300589 | Tianjin Ji Kun Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
62 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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