YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 288 drug applications between 23 April 2021 and 29 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 28 drug names.

2021/04/23 – 2021/04/29

Period
2021/04/23 to 2021/04/29, 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
288
Drugs with new generic filings (by drug name, de-duplicated)
28
Accepted this week, now under review
0

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

288filings, 36 of them generic

By application type

Application typeFilings
Supplement144
New drug59
Generic36
Import25
Import re-registration16
Unspecified8

By drug type

Drug typeFilings
Chemical drug206
TCM46
Therapeutic biologic35
Prophylactic biologic1

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4123
2Rivaroxaban Tablets323
3Ornidazole Injection210
4Obeticholic Acid Tablets210
5Vitamin K1 Injection216
6Sodium Valproate Concentrated Solution for Injection110
7Risperidone Oral Solution116
8Montelukast Sodium Chewable Tablets114
9Tenofovir alafenamide Fumarate Tablets110
10Levofloxacin Tablets117

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

157 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized25250
2AstraZeneca AB720
3Xian Jing Xi Shuang He Pharma Co., Ltd. romanized610
4Novartis Pharma Schweiz AG520
5Sichuan Kelun Pharmaceutical Co., Ltd.520
6Hebei Tian Zhi Pharma Co., Ltd. romanized520
7Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized440
8Yan Tai Yuan Sheng Pharma Co., Ltd. romanized430
9Shanghai Quan Yu Bio Technology (Zhu Ma Dian) Pharma Co., Ltd. romanized420
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420

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

86 this week

AcceptedDrugApplicants
2021/04/28Generic · Class 3 Tirofiban Hydrochloride InjectionCYHS2101113 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/04/28New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101048 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/28New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101047 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/28New drug · Class 2.2 西罗莫司滴眼液 · No verified English nameCXHL2101092 Fuzhou Hao Ji Pharmaceuticals Technology Development Co., Ltd. romanized
2021/04/27Import · Class 1 Cetrelimab · No verified English nameJXSL2101017 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/04/27Import · Class 1 泽弗利单抗注射液 · No verified English nameJXSL2101015 Agenus Inc.; Betta Pharmaceuticals Co. Ltd.
2021/04/27Import · Class 2.2 TAR-200 · No verified English nameJXHL2101020 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/04/27Import · Class 2.4 Selpercatinib胶囊 · No verified English nameJXHL2101019 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/04/27Import · Class 2.4 Selpercatinib胶囊 · No verified English nameJXHL2101018 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/04/27Generic · Class 3 Lansoprazole For InjectionCYHS2101110 Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2021/04/27New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101046 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2021/04/27New drug · Class 1 GNC-035四特异性抗体注射液 · No verified English nameCXSL2101045 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/04/27New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101043 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/04/27New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101042 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/04/27New drug · Class 1 CAN106注射液 · No verified English nameCXSL2101041 Nuo Ai Pharma (Shanghai) Co., Ltd. romanized
2021/04/27New drug · Class 1 EX103注射液 · No verified English nameCXSL2101037 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2021/04/27New drug · Class 1 SHR6390片 · No verified English nameCXHS2101008 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/27New drug · Class 1 SHR6390片 · No verified English nameCXHS2101007 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/27New drug · Class 1 SHR6390片 · No verified English nameCXHS2101006 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/27New drug · Class 1 SHR6508注射液 · No verified English nameCXHL2101089 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/27New drug · Class 2.2 氨酚氢可酮缓释片 · No verified English nameCXHL2101088 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/04/27New drug · Class 2.2 巯嘌呤微片 · No verified English nameCXHL2101087 Shou Du Yi Ke University Fu Shu Beijing Er Tong Hospital romanized
2021/04/27New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2101086 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2021/04/27New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2101085 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2021/04/27New drug · Class 1 注射用MT1013 · No verified English nameCXHL2101084 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2021/04/27New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101083 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/27New drug · Class 1 YS001胶囊 · No verified English nameCXHL2101082 Suzhou Ze Run Xin Yao Research and Development Co., Ltd. romanized
2021/04/27New drug · Class 1 TQB3811片 · No verified English nameCXHL2101081 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/27New drug · Class 1 TQB3811片 · No verified English nameCXHL2101080 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/26Import · Class 1 IMG-020注射液 · No verified English nameJXSL2101014 Affibody AB; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.

56 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.