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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 269 drug applications between 18 April 2022 and 24 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 37 drug names.

2022/04/18 – 2022/04/24

Period
2022/04/18 to 2022/04/24, 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
269
Drugs with new generic filings (by drug name, de-duplicated)
37
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

269filings, 52 of them generic

By application type

Application typeFilings
Supplement153
Generic52
New drug34
Import16
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug193
Therapeutic biologic38
TCM30
Biologic4
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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cariprazine hydrochloride Capsules413
2Rivaroxaban Tablets313
3Palbociclib Tablets312
4盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
5Pirfenidone Tablets225
6Levodopa and Benserazide Hydrochloride Tablets222
7Tadalafil Tablets2123
8司替戊醇干混悬剂 · No verified English name210
9Levetiracetam Tablets216
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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized15140
2Nanchang Bai Ji Pharmaceutical Co., Ltd. romanized870
3Bristol-Myers Squibb Pharma EEIG820
4Qilu Pharmaceutical Co., Ltd.734
5Yi Chang Ren Fu Pharma Co., Ltd. romanized723
6Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized710
7Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized550
8ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.524
9Merck Sharp & Dohme Corp.420
10AstraZeneca UK Limited410

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

72 this week

AcceptedDrugApplicants
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.
2022/04/24New drug · Class 2.2 HY-071221口服溶液 · No verified English nameCXHL2200254 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2022/04/24New drug · Class 1 BGM0504注射液 · No verified English nameCXHL2200253 Bo Rui Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/04/24New drug · Class 1 BR790片 · No verified English nameCXHL2200252 Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized
2022/04/22Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2200015 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd
2022/04/22Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2200014 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd
2022/04/22Import · Class 1 Fosmanogepix 注射液 · No verified English nameJXHL2200089 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/04/22Import · Class 1 Fosmanogepix 片 · No verified English nameJXHL2200088 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/04/22Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2200633 Ya Bao Pharma Group Co., Ltd. romanized
2022/04/22Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2200632 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2022/04/22Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200631 Di Kang Bei (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/22Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200630 Di Kang Bei (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/22Generic · Class 3 酮康唑泡沫剂 · No verified English nameCYHL2200033 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized
2022/04/22New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSS2200040 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2022/04/22New drug · Class 1 注射用BAT8010 · No verified English nameCXSL2200184 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2022/04/22New drug · Class 1 重组人神经调节蛋白-1-抗HER3抗体融合蛋白注射液 · No verified English nameCXSL2200177 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/04/22New drug · Class 1 注射用CIGB-814 · No verified English nameCXHL2200251 Shandong Lukang Pharmaceutical Co.,Ltd.

42 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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