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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 22 July 2022 and 28 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 36 drug names.

2022/07/22 – 2022/07/28

Period
2022/07/22 to 2022/07/28, 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
320
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

320filings, 47 of them generic

By application type

Application typeFilings
Supplement206
Generic47
New drug41
Import18
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug225
TCM63
Therapeutic biologic29
Prophylactic biologic2
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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Moxifloxacin Hydrochloride Eye Drops324
2Galantamine Hydrobromide Orally Disintegrating Tablets310
3Ibuprofen Injection218
4Tandospirone Citrate Tablets212
5Palonosetron Hydrochloride Injection211
6Dapoxetine Hydrochloride Tablets2120
7Lanthanum Carbonate Chewable Tablets212
8Minoxidil Topical Solution210
9Rocuronium Bromide Injection211
10二甲双胍恩格列净片(Ⅰ) · No verified English name117

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

142 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized73560
2Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized12120
3Sichuan Di Fei Te Pharma Co., Ltd. romanized10100
4Sui Cheng Pharma Co., Ltd. romanized651
5AstraZeneca UK Limited620
6Celgene Corporation610
7Hubei Mei Si Chuang Pharma Co., Ltd. romanized550
8Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized550
9Eli Lilly Nederland B.V.420
10Le Tai Pharma Co., Ltd. romanized330

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
2022/07/28Import · Class 3.1 ACYW群脑膜炎球菌多糖结合疫苗 · No verified English nameJXSL2200130 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2022/07/28Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2201160 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/07/28Generic · Class 3 Sodium cromoglicate solution for inhalationCYHS2201159 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200345 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200344 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 1 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200343 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 2.2 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSL2200342 Ningbo Rong An Bio Pharma Co., Ltd. romanized
2022/07/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200341 Shanghai Quan Sheng Bio Technology Co., Ltd. romanized
2022/07/28New drug · Class 1 YH01注射液 · No verified English nameCXSL2200340 Beijing Yin Mei Wei Lai Biopharmaceuticals Technology Co., Ltd. romanized
2022/07/28New drug · Class 2.1 泰它西普注射液 · No verified English nameCXSL2200325 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/07/28New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHS2200041 Shenzhen Han Yu Pharma Co., Ltd. romanized
2022/07/28New drug · Class 1 IN10018片 · No verified English nameCXHL2200541 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/07/28New drug · Class 1 IN10018片 · No verified English nameCXHL2200540 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
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.

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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