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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 466 drug applications between 5 May 2023 and 11 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 59 drug names.

2023/05/05 – 2023/05/11

Period
2023/05/05 to 2023/05/11, 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
466
Drugs with new generic filings (by drug name, de-duplicated)
59
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

466filings, 77 of them generic

By application type

Application typeFilings
Supplement254
New drug88
Generic77
Import25
Import re-registration12
Unspecified10

By drug type

Drug typeFilings
Chemical drug313
TCM86
Therapeutic biologic66
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

59 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
5Famotidine Injection228
6Roxatidine Acetate Hydrochloride For Injection225
7Minoxidil Liniment2252
8Crisaborole Ointment2126
9Carbazochrome Sodium Sulfonate Injection211
10Vonoprazan Fumarate Tablets2160

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized31280
2Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized28230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized15140
4Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized1210
5Eli Lilly and Company920
6Novo Nordisk A/S820
7Bard Pharmaceuticals Limited730
8Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized660
9Qilu Pharmaceutical (Hainan) Co., Ltd624
10AbbVie Limited610

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

142 this week

AcceptedDrugApplicants
2023/05/11Import · Class 1 EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300114 EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd.
2023/05/11Import · Class 1 EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300113 EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd.
2023/05/11Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2300112 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2023/05/11Generic · Class 3 Famotidine InjectionCYHS2301278 Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 Famotidine InjectionCYHS2301277 Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301276 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/05/11Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2301274 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/05/11Generic · Class 3 Peramivir InjectionCYHS2301271 Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized
2023/05/11New drug · Class 1 注射用A166 · No verified English nameCXSS2300034 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/05/11New drug · Class 1 FL115注射液 · No verified English nameCXSL2300329 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2023/05/11New drug · Class 1 ReT01 ACT 注射液 · No verified English nameCXSL2300328 Beijing An Wei Sen Biopharmaceuticals Co., Ltd. romanized
2023/05/11New drug · Class 1 ISM8207胶囊 · No verified English nameCXHL2300508 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/05/11New drug · Class 1 ISM8207胶囊 · No verified English nameCXHL2300507 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/05/11New drug · Class 1 ISM8207胶囊 · No verified English nameCXHL2300506 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/05/11New drug · Class 1 ICP-723口崩片 · No verified English nameCXHL2300505 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2023/05/11New drug · Class 1 注射用TFX05-01 · No verified English nameCXHL2300504 Shenzhen Yang Li Pharmaceuticals Technology Co., Ltd. romanized
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

112 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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