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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 200 drug applications between 31 December 2021 and 6 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 25 drug names.

2021/12/31 – 2022/01/06

Period
2021/12/31 to 2022/01/06, 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
200
Drugs with new generic filings (by drug name, de-duplicated)
25
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

200filings, 36 of them generic

By application type

Application typeFilings
Supplement93
New drug47
Generic36
Import15
Import re-registration8
Unspecified1

By drug type

Drug typeFilings
Chemical drug146
Therapeutic biologic39
TCM15

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gabapentin Capsules310
2Enarodustat Tablets310
3Losartan Potassium and Hydrochlorothiazide Tablets311
4Nicorandil for Injection311
5地氯雷他定口服溶液 · No verified English name2226
6Metoprolol Tartrate Tablets223
7Dobutamine Hydrochloride Injection213
8Lactulose Oral Solution1134
9Voriconazole for Oral Suspension111
10Compound Ipratropium Bromide Solution For Inhalation114

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

125 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized660
2Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
3Pfizer Europe MA EEIG420
4Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized420
5Nian Yan Pharma (Zhuhai) Co., Ltd. romanized410
6Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized410
7Yi Chang Ren Fu Pharma Co., Ltd. romanized333
8Hubei Rui Ze Pharma Co., Ltd. romanized330
9Boehringer Ingelheim International GmbH320
10Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized310

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

67 this week

AcceptedDrugApplicants
2022/01/06Import · Class 1 MRTX849片 · No verified English nameJXHL2200006 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/01/06Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2200014 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shandong Yi Kang Pharma Co., Ltd. romanized
2022/01/06New drug · Class 1 PM1015 注射液 · No verified English nameCXSL2200006 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/01/06New drug · Class 1 HLX301 · No verified English nameCXSL2200005 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/01/06New drug · Class 1 重组人源化抗PD-L1单克隆抗体/人TGF-β融合蛋白注射液 · No verified English nameCXSL2101535 Le Pu Bio Technology Co., Ltd. romanized
2022/01/06New drug · Class 1 CP0119片 · No verified English nameCXHL2200008 Nan Kai University romanized
2022/01/06New drug · Class 1 CP0119片 · No verified English nameCXHL2200007 Nan Kai University romanized
2022/01/05Import · Class 1 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2200002 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai)Co. Ltd
2022/01/05Import · Class 1 SQZ-AAC-HPV · No verified English nameJXSL2200001 SQZ Biotechnologies Company; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/01/05Import · Class 1 SHR8008胶囊 · No verified English nameJXHS2101101 eVENUS PHARMACEUTICAL LABORATORIES INC.; PATHEON INC.; Jiangsu Hengrui Pharmaceuticals Co. Ltd
2022/01/05Import · Class 1 ATG-016片 · No verified English nameJXHL2200002 Karyopharm Therapeutics Inc.; Shanghai Antengene Corporation Limited
2022/01/05Import · Class 1 ATG-016片 · No verified English nameJXHL2200001 Karyopharm Therapeutics Inc.; Shanghai Antengene Corporation Limited
2022/01/05Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2200008 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/01/05Generic · Class 3 Loxoprofen sodium hydrate gelCYHS2102309 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2022/01/05New drug · Class 1.2 岩藻多糖胶囊 · No verified English nameCXZL2200002 Wei Hai Ren Sheng Pharma Co., Ltd. romanized
2022/01/05New drug · Class 1.2 岩藻多糖硫酸酯 · No verified English nameCXZL2200001 Wei Hai Ren Sheng Pharma Co., Ltd. romanized
2022/01/05New drug · Class 3.3 阿柏西普眼内注射溶液 · No verified English nameCXSL2200003 Zhi En Bio Technology Co., Ltd. romanized
2022/01/05New drug · Class 1 SK08活菌散 · No verified English nameCXSL2200001 Guangzhou Zhi Yi Bio Technology Co., Ltd. romanized
2022/01/05New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2101537 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/01/05New drug · Class 2.3 可溶性甘精赖脯双胰岛素注射液 · No verified English nameCXSL2101513 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2022/01/05New drug · Class 1 HRS-7535片 · No verified English nameCXHL2200006 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/01/05New drug · Class 1 HRS-7535片 · No verified English nameCXHL2200005 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/01/05New drug · Class 1 NT-004片 · No verified English nameCXHL2200004 Nian Yan Pharma (Zhuhai) Co., Ltd. romanized
2022/01/05New drug · Class 1 NT-004片 · No verified English nameCXHL2200003 Nian Yan Pharma (Zhuhai) Co., Ltd. romanized
2022/01/05New drug · Class 1 NT-004片 · No verified English nameCXHL2200002 Nian Yan Pharma (Zhuhai) Co., Ltd. romanized
2022/01/05New drug · Class 1 NT-004片 · No verified English nameCXHL2200001 Nian Yan Pharma (Zhuhai) Co., Ltd. romanized
2022/01/05New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2101861 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/01/05New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2101860 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/01/05New drug · Class 1 希列克托灵片 · No verified English nameCXHL2101833 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized
2022/01/05New drug · Class 1 希列克托灵片 · No verified English nameCXHL2101832 Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized

37 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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