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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 21 July 2022 and 27 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 33 drug names.

2022/07/21 – 2022/07/27

Period
2022/07/21 to 2022/07/27, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
33
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

308filings, 47 of them generic

By application type

Application typeFilings
Supplement192
Generic47
New drug37
Import19
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug214
TCM62
Therapeutic biologic31
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Aripiprazole Oral Solution414
2Moxifloxacin Hydrochloride Eye Drops324
3Galantamine Hydrobromide Orally Disintegrating Tablets310
4Ibuprofen Injection218
5Nicorandil for Injection211
6Palonosetron Hydrochloride Injection211
7Dapoxetine Hydrochloride Tablets2120
8Lanthanum Carbonate Chewable Tablets212
9Minoxidil Topical Solution210
10Rocuronium Bromide Injection211

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized73560
2Sichuan Di Fei Te Pharma Co., Ltd. romanized13130
3Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized12120
4AstraZeneca UK Limited620
5Celgene Corporation610
6Hubei Mei Si Chuang Pharma Co., Ltd. romanized550
7Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized550
8Sui Cheng Pharma Co., Ltd. romanized540
9Pfizer Europe MA EEIG520
10Eli Lilly Nederland B.V.420

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

74 this week

AcceptedDrugApplicants
2022/07/27Import · Class 3.1 帕妥珠单抗曲妥珠单抗注射液(皮下注射) · No verified English nameJXSS2200027 Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche Ltd
2022/07/27Import · Class 3.1 帕妥珠单抗曲妥珠单抗注射液(皮下注射) · No verified English nameJXSS2200026 Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche Ltd
2022/07/27Generic · Class 3 Galantamine Hydrobromide Orally Disintegrating TabletsCYHS2201156 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2022/07/27Generic · Class 3 Galantamine Hydrobromide Orally Disintegrating TabletsCYHS2201155 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2022/07/27Generic · Class 3 Galantamine Hydrobromide Orally Disintegrating TabletsCYHS2201154 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2022/07/27Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201147 Ji Chuan Pharma Group Co., Ltd. romanized
2022/07/27Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2201146 Le Pu Pharma Co., Ltd. romanized
2022/07/27Generic · Class 3 Regadenoson InjectionCYHS2201142 Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2022/07/27New drug · Class 1 注射用STSP-0601 · No verified English nameCXSL2200333 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized; Beijing Nuo Wei Kang Pharmaceuticals Technology Co., Ltd. romanized
2022/07/27New drug · Class 2.2 YZJT-1705注射液 · No verified English nameCXHL2200539 Zhongguo Ke College Shanghai Drug Research Institute romanized; Yangtze River Pharmaceutical Group Co., Ltd
2022/07/27New drug · Class 2.4 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2200538 Shanghai Yi Zhong Pharma Co., Ltd. romanized
2022/07/26Import · Class 3.1 Galcanezumab注射液 · No verified English nameJXSS2200028 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2022/07/26Import · Class 1 BI 1015550 片 · No verified English nameJXHL2200217 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/07/26Import · Class 1 BI 1015550 片 · No verified English nameJXHL2200216 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/07/26Import · Class 1 BLU-701片 · No verified English nameJXHL2200215 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/07/26Import · Class 1 BLU-701片 · No verified English nameJXHL2200214 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/07/26Generic · Class 3 Minoxidil Topical SolutionCYHS2201144 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2022/07/26Generic · Class 3 Minoxidil Topical SolutionCYHS2201143 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2022/07/26Generic · Class 3 Ibuprofen InjectionCYHS2201140 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2022/07/26Generic · Class 3 Ibuprofen InjectionCYHS2201139 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2022/07/26Generic · Class 3 Calcium Gluconate InjectionCYHS2201138 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2022/07/26New drug · Class 1 因诺替西尔替-ESO细胞注射液 · No verified English nameCXSL2200338 Shenzhen Yin Nuo Mian Yi Co., Ltd. romanized; Hangzhou Chao Mei Bio Technology Co., Ltd. romanized
2022/07/26New drug · Class 1 因诺替西尔替-ESO细胞注射液 · No verified English nameCXSL2200337 Shenzhen Yin Nuo Mian Yi Co., Ltd. romanized; Hangzhou Chao Mei Bio Technology Co., Ltd. romanized
2022/07/26New drug · Class 1 AK112注射液 · No verified English nameCXSL2200336 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2022/07/26New drug · Class 1 AK119注射液 · No verified English nameCXSL2200335 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/07/26New drug · Class 2.2 SY-201滴眼液 · No verified English nameCXHL2200537 Sheng Yuan Pharmaceuticals Guangzhou Co., Ltd. romanized
2022/07/26New drug · Class 2.2 SY-201滴眼液 · No verified English nameCXHL2200536 Sheng Yuan Pharmaceuticals Guangzhou Co., Ltd. romanized
2022/07/26New drug · Class 2.2 SY-201滴眼液 · No verified English nameCXHL2200535 Sheng Yuan Pharmaceuticals Guangzhou Co., Ltd. romanized
2022/07/26New drug · Class 2.2 氨酚羟考酮缓释片 · No verified English nameCXHL2200533 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/07/26New drug · Class 1 GFH312 片 · No verified English nameCXHL2200532 Zhejiang Jin Fang Pharma Co., Ltd. romanized

44 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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