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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 187 drug applications between 26 April 2022 and 2 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 27 drug names.

2022/04/26 – 2022/05/02

Period
2022/04/26 to 2022/05/02, 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
187
Drugs with new generic filings (by drug name, de-duplicated)
27
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

187filings, 38 of them generic

By application type

Application typeFilings
Supplement108
Generic38
New drug24
Unspecified9
Import8

By drug type

Drug typeFilings
Chemical drug142
TCM20
Therapeutic biologic20
Biologic4
Prophylactic 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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nifedipine Controlled-release Tablets337
2Ibuprofen Suspension2214
3Sodium Valproate Concentrated Solution for Injection210
4Nintedanib Esilate Soft Capsules216
5Digoxin Injection213
6Ornidazole Injection210
7Dimethyl Fumarate Delayed-release Capsules210
8Levofloxacin and Sodium Chloride Injection2114
9Budesonide Nasal Spray213
10Iopromide Injection2127

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

117 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized610
2Henan Tai Long Pharma Co., Ltd. romanized550
3Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized510
4Wu Hu Dao Run Pharma Co., Ltd. romanized440
5Le Pu Pharma Co., Ltd. romanized421
6MINGHUI PHARMACEUTICAL PTY LTD410
7Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
8Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized320
9Sichuan Tai Ping Yang Pharma Co., Ltd. romanized320
10Eli Lilly Nederland B.V.310

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

41 this week

AcceptedDrugApplicants
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200094 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200093 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200092 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200091 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200694 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/04/29Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2200689 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2022/04/29Generic · Class 3 Ibuprofen InjectionCYHS2200644 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/04/29New drug · Class 1.2 甘草总查耳酮胶囊 · No verified English nameCXZL2200021 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2022/04/29New drug · Class 1.2 甘草总查耳酮 · No verified English nameCXZL2200020 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2022/04/29New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2200049 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200048 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200047 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200046 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200045 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 注射用LB4330 · No verified English nameCXSL2200187 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2022/04/29New drug · Class 1 注射用K11 · No verified English nameCXSL2200186 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2022/04/29New drug · Class 1 DZD1516片 · No verified English nameCXHL2200270 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/04/29New drug · Class 1 DZD1516片 · No verified English nameCXHL2200269 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/04/29New drug · Class 1 ICP-490片 · No verified English nameCXHL2200267 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/04/29New drug · Class 1 ICP-490片 · No verified English nameCXHL2200266 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/04/29New drug · Class 2.2 黄体酮长效注射液 · No verified English nameCXHL2200265 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/04/29New drug · Class 2.2 黄体酮长效注射液 · No verified English nameCXHL2200264 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/04/29New drug · Class 1 WS015干混悬剂 · No verified English nameCXHL2200255 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2022/04/28Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200687 Sichuan Zi Ren Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Ozagrel Sodium InjectionCYHS2200686 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/04/28Generic · Class 3 布洛芬混悬滴剂 · No verified English nameCYHS2200685 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Digoxin InjectionCYHS2200680 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/04/28Generic · Class 3 Digoxin InjectionCYHS2200679 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/04/28Generic · Class 3 Ornidazole InjectionCYHS2200678 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2022/04/28Generic · Class 3 Ornidazole InjectionCYHS2200677 Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized

11 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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