YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 261 drug applications between 20 April 2022 and 26 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 36 drug names.

2022/04/20 – 2022/04/26

Period
2022/04/20 to 2022/04/26, 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
261
Drugs with new generic filings (by drug name, de-duplicated)
36
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

261filings, 49 of them generic

By application type

Application typeFilings
Supplement143
Generic49
New drug35
Import14
Unspecified13
Import re-registration7

By drug type

Drug typeFilings
Chemical drug191
Therapeutic biologic37
TCM23
Biologic6
Prophylactic biologic4

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cariprazine hydrochloride Capsules413
2Cefminox Sodium for Injection310
3Pirfenidone Tablets225
4Tandospirone Citrate Tablets222
5氧(液态) · No verified English name2213
6Sodium Valproate Concentrated Solution for Injection210
7Tacrolimus Ointment216
8司替戊醇干混悬剂 · No verified English name210
9Temozolomide Capsules210
10磷酸奥司他韦干糖浆 · No verified English name210

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

164 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bristol-Myers Squibb Pharma EEIG820
2Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized710
3Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized660
4Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized550
5Pfizer Inc.530
6ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.524
7GUERBET410
8Yi Chang Ren Fu Pharma Co., Ltd. romanized410
9Hainan Zhong Yue Medical Health Industry Co., Ltd. romanized330
10Nanjing Cheng Tong Biopharmaceutical Technology Development 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

68 this week

AcceptedDrugApplicants
2022/04/26Import · Class 2.2 那西妥单抗注射液 · No verified English nameJXSL2200047 Y-mAbs Therapeutics Inc.; SciClone Pharmaceuticals (China) Co. Ltd.
2022/04/26Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200660 Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/04/26Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200659 Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2022/04/26New drug · Class 1 HB0034注射液 · No verified English nameCXSL2200191 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/04/26New drug · Class 1 HLX53 · No verified English nameCXSL2200190 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/04/25Generic · Class 3 Citicoline InjectionCYHS2200652 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/04/25Generic · Class 3 Tranexamic Acid InjectionCYHS2200651 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/04/25Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200649 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2022/04/25New drug · Class 2.2 尼妥珠单抗注射液 · No verified English nameCXSS2200041 Bai Tai Bio Pharma Co., Ltd. romanized
2022/04/25New drug · Class 3.4 治疗用卡介苗 · No verified English nameCXSL2200188 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/04/25New drug · Class 2.2 盐酸伊立替康脂质体注射液 · No verified English nameCXHS2200019 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/04/25New drug · Class 1 SC0062胶囊 · No verified English nameCXHL2200260 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 RJ4287片 · No verified English nameCXHL2200259 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 RJ4287片 · No verified English nameCXHL2200258 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/04/25New drug · Class 1 TSN333片 · No verified English nameCXHL2200257 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2022/04/25New drug · Class 1 TSN333片 · No verified English nameCXHL2200256 Tai Li Bio Technology (Shanghai) Co., Ltd. romanized
2022/04/24Import · Class 2.2 Efgartigimod浓缩注射液 · No verified English nameJXSL2200050 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2022/04/24Import · Class 2.4 达罗他胺片 · No verified English nameJXHS2200041 Bayer HealthCare Pharmaceuticals Inc.; Orion Corporation,Orion Pharma,Espoo; Bayer Healthcare Company Ltd.
2022/04/24Import · Class 2.4 Ibrexafungerp片 · No verified English nameJXHL2200090 SCYNEXIS Inc.; JIANGSU HANSOH PHARMACEUTICAL GROUP CO. LTD
2022/04/24Generic · Class 3 Pirfenidone TabletsCYHS2200634 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2022/04/24Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200039 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/04/24Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200038 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/04/24Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200037 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/04/24Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200036 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/04/24Generic · Class 3 Regadenoson InjectionCYHL2200035 Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized
2022/04/24New drug · Class 3.3 肠道病毒71型灭活疫苗(Vero细胞) · No verified English nameCXSS2200043 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/04/24New drug · Class 3.3 肠道病毒71型灭活疫苗(Vero细胞) · No verified English nameCXSS2200042 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/04/24New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200185 Chongqing Pai Jin Bio Technology Co., Ltd. romanized; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2022/04/24New drug · Class 1 CMAB017注射液 · No verified English nameCXSL2200183 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2022/04/24New drug · Class 1 安达西尼胶囊 · No verified English nameCXHS2200018 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.

38 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.