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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 395 drug applications between 4 May 2023 and 10 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.

2023/05/04 – 2023/05/10

Period
2023/05/04 to 2023/05/10, 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
395
Drugs with new generic filings (by drug name, de-duplicated)
52
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

395filings, 68 of them generic

By application type

Application typeFilings
Supplement200
New drug84
Generic68
Import22
Import re-registration12
Unspecified9

By drug type

Drug typeFilings
Chemical drug269
TCM63
Therapeutic biologic62
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dasatinib Tablets414
2Arginine and Ibuprofen Granules3111
3Indobufen Tablets226
4Levofloxacin Eye Drops2216
5Roxatidine Acetate Hydrochloride For Injection225
6Minoxidil Liniment2252
7Crisaborole Ointment2126
8Carbazochrome Sodium Sulfonate Injection211
9Nimodipine Oral Solution214
10Fluorouracil Injection216

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized28230
2An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized19170
3Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized1210
4Eli Lilly and Company920
5Novo Nordisk A/S820
6Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized660
7Bard Pharmaceuticals Limited620
8Qilu Pharmaceutical (Hainan) Co., Ltd624
9AbbVie Limited610
10Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized520

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

131 this week

AcceptedDrugApplicants
2023/05/10Import · Class 1 Eplontersen注射液 · No verified English nameJXHL2300111 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/05/10Import · Class 1 注射用Redasemtide · No verified English nameJXHL2300110 Shionogi & Co. Ltd.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300109 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300108 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300107 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300106 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300105 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Import · Class 1 LY3502970胶囊 · No verified English nameJXHL2300104 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/05/10Generic · Class 3 Dequalinium Chloride Buccal TabletsCYHS2301269 Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized
2023/05/10Generic · Class 3 Minoxidil Topical SolutionCYHS2301266 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2023/05/10Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301262 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2023/05/10Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301261 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2023/05/10Generic · Class 3 Levofloxacin Oral SolutionCYHS2301258 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/05/10Generic · Class 3 Potassium Chloride GranulesCYHS2301257 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/05/10Generic · Class 3 Indobufen TabletsCYHS2301256 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/05/10New drug · Class 2.1 银黄吸入溶液 · No verified English nameCXZL2300033 Zhejiang Wei Kang Pharma Co., Ltd. romanized; Ying Ke Rui (Heng Qin) Drug Research Institute Co., Ltd. romanized
2023/05/10New drug · Class 1 注射用9MW2921 · No verified English nameCXSL2300327 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 注射用7MW3711 · No verified English nameCXSL2300326 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/05/10New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300324 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/05/10New drug · Class 1 重组NV-A01腺病毒注射液 · No verified English nameCXSL2300323 Nanjing Nuo Wei Bio Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 CKBA软膏 · No verified English nameCXHL2300503 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 CKBA软膏 · No verified English nameCXHL2300502 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 CKBA软膏 · No verified English nameCXHL2300501 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 CKBA软膏 · No verified English nameCXHL2300500 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/10New drug · Class 1 CKBA软膏 · No verified English nameCXHL2300499 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2023/05/10New drug · Class 2.2 GRCE2101 · No verified English nameCXHL2300498 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/05/10New drug · Class 1 ZB-001干混悬剂 · No verified English nameCXHL2300497 Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2023/05/10New drug · Class 1 注射用HRS-7053 · No verified English nameCXHL2300496 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/05/09Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301255 Hefei Hao Yi Pharmaceuticals Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/05/09Generic · Class 3 Nimodipine Oral SolutionCYHS2301254 Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized

101 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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