YaoGeJu

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

Period
2023/05/25 to 2023/05/31, 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
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 typeFilings
Supplement122
Generic70
New drug25
Import18
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug174
TCM46
Therapeutic biologic28
Prophylactic biologic3
In vitro diagnostic reagent1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxacillin Sodium for Injection5213
2Roxadustat Capsules4217
3Selexipag Tablets3124
4Tranexamic Acid Injection3111
5Desvenlafaxine Extended-release Tablets310
6阿普米司特片 · No verified English name313
7Famotidine Injection228
8Dopamine Hydrochloride Injection223
9Doxofylline Injection215
10Ropinirole Hydrochloride Sustained-release Tablets212

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)FilingsDrugsGeneric
1Eli Lilly and Company610
2An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized550
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
4Pfizer Inc.530
5Chongqing Sai Wei Pharma Co., Ltd. romanized510
6AstraZeneca AB420
7Yi Chang Ren Fu Pharma Co., Ltd. romanized423
8Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized320
9HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.320
10Anhui Lei Yun Shang Pharma Co., Ltd. romanized320

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

AcceptedDrugApplicants
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.

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.