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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 18 February 2023 and 24 February 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 90, covering 65 drug names.

2023/02/18 – 2023/02/24

Period
2023/02/18 to 2023/02/24, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
389
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
1

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

389filings, 90 of them generic

By application type

Application typeFilings
Supplement213
Generic90
New drug37
Import26
Import re-registration20
Unspecified3

By drug type

Drug typeFilings
Chemical drug284
TCM57
Therapeutic biologic40
Prophylactic biologic8

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4323
2Oseltamivir Phosphate Capsules4239
3Tranexamic Acid Injection3111
4Duloxetine Hydrochloride Enteric Capsules314
5Lidocaine and Prilocaine Cream2224
6Roxatidine Acetate Hydrochloride For Injection226
7Sodium Hyaluronate Eye Drops2232
8Acetaminophen Injection211
9Levetiracetam extended-release tablets210
10Levofloxacin Tablets217

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

232 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Jun Yuan Pharma Co., Ltd. romanized16100
2Guangxi Yu Yuan Pharma Co., Ltd. romanized1290
3Rui Yang Pharmaceutical Co., Ltd. romanized633
4Chongqing Qian Fang Drug Research Co., Ltd. romanized540
5Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized540
6Sichuan Kelun Pharmaceutical Co., Ltd.532
7Pfizer Inc.520
8Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized440
9Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized434
10Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized430

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

90 this week

AcceptedDrugApplicants
2023/02/24Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300018 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/02/24Import · Class 2.2 佩索利单抗注射液 · No verified English nameJXSL2300042 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/02/24Import · Class 2.2 佩索利单抗注射液 · No verified English nameJXSL2300041 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/02/24Import · Class 1 注射用舒巴坦钠/注射用度洛巴坦钠组合包装 · No verified English nameJXHS2300022 Entasis Therapeutics Inc.; MITIM S.R.L.; Lyophilization Services of New England Inc. (LSNE); Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/02/24Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2300034 AbbVie Inc.
2023/02/24Generic · Class 3 Ebastine Oral SolutionCYHS2300635 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2300633 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Furosemide TabletsCYHS2300631 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hua Zhong Pharma Co., Ltd. romanized
2023/02/24Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2300626 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/02/24Generic · Class 3 注射用贝林司他 · No verified English nameCYHL2300029 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/02/24Generic · Class 3 Methylergonovine Maleate InjectionCYHL2300028 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2023/02/24New drug · Class 1 重组人源化抗Claudin 18.2单克隆抗体注射液 · No verified English nameCXSL2300155 Kai Xing Sheng Ming Technology (Shanghai) Co., Ltd. romanized; Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2023/02/24New drug · Class 1 SHR-2017注射液 · No verified English nameCXSL2300154 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/02/24New drug · Class 1 HBM1020注射液 · No verified English nameCXSL2300153 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/02/24New drug · Class 1 S086片 · No verified English nameCXHL2300248 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/02/23Import · Class 3.1 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSL2300040 Janssen-Cilag International NV; Johnson &Johnson(China)Investment Ltd.
2023/02/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2300625 Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2023/02/23Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2300622 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2023/02/23Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300617 Hangzhou He Kang Pharma Co., Ltd. romanized
2023/02/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2300615 Henan Lan Tu Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/02/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2300614 Henan Lan Tu Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/02/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300152 Suzhou Tuo Hua Bio Technology Co., Ltd. romanized
2023/02/23New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2300151 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 1 NWRD06裸质粒DNA注射液 · No verified English nameCXSL2300150 Nuo Wei Technology (Tai Zhou) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized
2023/02/23New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2300149 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2300148 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 1 QR052107B片 · No verified English nameCXHL2300247 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/02/23New drug · Class 1 QR052107B片 · No verified English nameCXHL2300246 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/02/23New drug · Class 2.3 复方果糖电解质注射液 · No verified English nameCXHL2300245 Shanghai Zhi Zhen Bio Technology Co., Ltd. romanized
2023/02/23New drug · Class 2.2 HF158K1 · No verified English nameCXHL2300244 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized

60 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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