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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 297 drug applications between 8 March 2023 and 14 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 48 drug names.

2023/03/08 – 2023/03/14

Period
2023/03/08 to 2023/03/14, 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
297
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
10

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

297filings, 64 of them generic

By application type

Application typeFilings
Supplement153
Generic64
New drug43
Import18
Import re-registration16
Unspecified3

By drug type

Drug typeFilings
Chemical drug222
Therapeutic biologic37
TCM33
Biologic3
Prophylactic 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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
2Lactulose Oral Solution2234
3氧 · No verified English name2215
4Famotidine Injection228
5Glucosamine Sulfate Capsules2251
6Risperidone Orally Disintegrating Tablets210
7吸入用布地奈德混悬液 · No verified English name217
8Obeticholic Acid Tablets210
9Dimethyl Fumarate Delayed-release Capsules210
10Empagliflozin And Linagliptin Tablets210

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tianjin He Zhi Pharma Group Co., Ltd. romanized990
2Shanghai Qing Ping Pharma Co., Ltd. romanized850
3Actelion Pharmaceuticals Ltd810
4Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized760
5Roche Pharma (Schweiz) AG720
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
7Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized550
8Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized530
9Qilu Pharmaceutical (Hainan) Co., Ltd535
10Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized440

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

86 this week

AcceptedDrugApplicants
2023/03/14Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2300027 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2023/03/14Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2300026 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2023/03/14Import · Class 1 DS-1062a · No verified English nameJXSL2300051 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/03/14Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2300047 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2023/03/14Generic · Class 3 Peramivir InjectionCYHS2300785 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2023/03/14Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2300779 Hunan Chun Jian Pharmaceuticals Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/03/14Generic · Class 3 Cefazolin Sodium for InjectionCYHS2300778 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized
2023/03/14Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300777 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2023/03/14Generic · Class 3 Nicorandil for InjectionCYHS2300776 Sichuan Bai Li Pharma Co., Ltd. romanized
2023/03/14New drug · Class 2.4 CMAB009注射液 · No verified English nameCXSS2300012 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2023/03/14New drug · Class 1 TQC2731注射液 · No verified English nameCXSL2300185 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/03/14New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300184 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/03/14New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300183 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/03/14New drug · Class 2.1; 2.2; 2.4 YMP透皮贴剂 · No verified English nameCXHL2300311 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2023/03/14New drug · Class 2.1; 2.2; 2.4 YMP透皮贴剂 · No verified English nameCXHL2300310 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2023/03/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2300309 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/03/14New drug · Class 1 HRS-5041片 · No verified English nameCXHL2300308 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/03/14New drug · Class 1 PE-001片 · No verified English nameCXHL2300306 Yuan Yan Yao Gang Sheng Ming Ke Xue Research (Liaoning) Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2023/03/14New drug · Class 1 PE-001片 · No verified English nameCXHL2300305 Yuan Yan Yao Gang Sheng Ming Ke Xue Research (Liaoning) Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2023/03/14New drug · Class 1 PE-001片 · No verified English nameCXHL2300304 Yuan Yan Yao Gang Sheng Ming Ke Xue Research (Liaoning) Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2023/03/13Import · Class 1 LY3454738注射液 · No verified English nameJXSL2300050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/03/13Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2300773 Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized
2023/03/13Generic · Class 3 Obeticholic Acid TabletsCYHL2300036 Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/03/13Generic · Class 3 Obeticholic Acid TabletsCYHL2300035 Hangzhou Minsheng Pharmaceutical Co., Ltd
2023/03/13New drug · Class 2.2 替格瑞洛缓释片 · No verified English nameCXHL2300303 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2023/03/11Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2300025 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2300024 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/03/11Import · Class 1 elranatamab · No verified English nameJXSL2300049 Pfizer Inc; Pfizer Investment CO. Ltd.
2023/03/11Import · Class 1 Zavegepant鼻喷雾剂 · No verified English nameJXHL2300044 Pfizer Inc.; Pfizer Investment CO. Ltd
2023/03/11Generic · Class 3 Empagliflozin And Linagliptin TabletsCYHS2300770 Qilu Pharmaceutical (Hainan) Co., Ltd

56 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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