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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 229 drug applications between 25 August 2022 and 31 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 38 drug names.

2022/08/25 – 2022/08/31

Period
2022/08/25 to 2022/08/31, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
2

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

229filings, 50 of them generic

By application type

Application typeFilings
Supplement102
Generic50
New drug41
Import21
Import re-registration8
Unspecified7

By drug type

Drug typeFilings
Chemical drug149
Therapeutic biologic55
TCM18
Prophylactic biologic5
Biologic2

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Solution For Inhalation224
2Tacrolimus Ointment216
3Perampanel Tablets212
4Piracetam Injection219
5Vortioxetine Hydrobromide Tablets2110
6Potassium Chloride Injection2110
7Ceftazidime for Injection214
8盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
9Memantine Hydrochloride Oral Solution210
10Moxifloxacin Hydrochloride Eye Drops214

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

133 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Roche Pharma (Schweiz) AG920
2Eli Lilly and Company720
3Shenyang San Sheng Pharmaceutical Co., Ltd. romanized722
4Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized660
5Chengdu Hong Ji Bio Technology Co., Ltd. romanized510
6Hubei Kang Wei Yuan Pharma Co., Ltd. romanized440
7CISEN PHARMACEUTICAL CO., LTD.433
8Pfizer Inc.420
9Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized420
10Hunan Ke Lun Pharmaceutical Co., Ltd. romanized420

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

75 this week

AcceptedDrugApplicants
2022/08/31Import · Class 1 注射用MK-2060 · No verified English nameJXSL2200150 Merck Sharp & Dohme LLC; Name not romanized
2022/08/31Import · Class 1 PF-07104091片 · No verified English nameJXHL2200267 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/08/31Import · Class 1 PF-07104091片 · No verified English nameJXHL2200266 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/08/31Import · Class 1 PF-07220060 · No verified English nameJXHL2200265 Pfizer Inc; Pfizer Investment CO. Ltd
2022/08/31Import · Class 2.4 阿贝西利片 · No verified English nameJXHL2200264 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/08/31Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2201420 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2022/08/31Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHL2200074 Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized
2022/08/31New drug · Class 1 人脐带间充质干细胞膜片 · No verified English nameCXSL2200430 Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200429 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200428 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200427 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200426 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200425 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 3.4 重组人神经生长因子滴眼液 · No verified English nameCXSL2200424 Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized
2022/08/31New drug · Class 1 BA2101注射液 · No verified English nameCXSL2200417 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 BA2101注射液 · No verified English nameCXSL2200416 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200409 Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized
2022/08/31New drug · Class 1 TR128胶囊 · No verified English nameCXHL2200640 Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized
2022/08/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200639 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/08/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200638 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/08/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200637 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/08/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200636 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/08/30Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2200149 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/08/30Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2200148 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/08/30Import · Class 1 SLS-005 · No verified English nameJXHL2200263 Seelos Therapeutics Inc.; Syneos Health (Beijing) Inc. Ltd.
2022/08/30Generic · Class 3 Magnesium Sulfate InjectionCYHS2201417 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/08/30Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2201411 Shandong Yi Kang Pharma Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200423 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200422 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200421 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized

45 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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