YaoGeJu

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

Period
2023/05/27 to 2023/06/02, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement127
Generic86
New drug35
Import20
Unspecified6
Import re-registration3

By drug type

Drug typeFilings
Chemical drug212
TCM35
Therapeutic biologic30

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection7313
2Lactulose Oral Solution4434
3Doxofylline Injection325
4Urapidil Hydrochloride Injection326
5Selexipag Tablets3124
6Tranexamic Acid Injection3111
7Desvenlafaxine Extended-release Tablets310
8阿普米司特片 · No verified English name313
9Peramivir Injection227
10Famotidine Injection228

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)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized10100
2An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized660
3Eli Lilly and Company610
4Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
5Chongqing Sai Wei Pharma Co., Ltd. romanized510
6AbbVie Inc.420
7Yi Chang Ren Fu Pharma Co., Ltd. romanized423
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
9Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized410
10Anhui Pioneer Pharmaceutical Co., Ltd333

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

AcceptedDrugApplicants
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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.