YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 3 December 2023 and 9 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 64 drug names.

2023/12/03 – 2023/12/09

Period
2023/12/03 to 2023/12/09, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
64
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, 92 of them generic

By application type

Application typeFilings
Supplement181
Generic92
New drug58
Import33
Unspecified13
Import re-registration12

By drug type

Drug typeFilings
Chemical drug251
TCM68
Therapeutic biologic57
Biologic10
Prophylactic biologic2
In vitro diagnostic reagent1

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Agomelatine Tablets338
2Levocarnitine Oral Solution329
3Minoxidil Liniment3252
4盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
5阿普米司特片 · No verified English name313
6Diprophylline Injection227
7Morinidazole and Sodium Chloride Injection229
8地氯雷他定口服溶液 · No verified English name2226
9Roxatidine Acetate Hydrochloride For Injection225
10甘油磷酸钠注射液 · No verified English name227

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized37280
2medac Gesellschaft für klinische Spezialpr?parate mbH810
3Novo Nordisk A/S720
4Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized545
5ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.543
6Sanofi-Aventis Recherche & Développement520
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
8Karuna Therapeutics Inc.510
9Janssen Research & Development LLC420
10Novartis Pharma AG410

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

116 this week

AcceptedDrugApplicants
2023/12/09Import · Class 1 MK-7240注射用浓溶液 · No verified English nameJXSL2300220 Merck Sharp & Dohme LLC; Name not romanized
2023/12/09Import · Class 1 MK-7240注射液 · No verified English nameJXSL2300219 Merck Sharp & Dohme LLC; Name not romanized
2023/12/09Import · Class 1 SAR441566 · No verified English nameJXHL2300311 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2023/12/09Import · Class 1 SAR441566 · No verified English nameJXHL2300310 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2023/12/09Import · Class 1 SAR441566 · No verified English nameJXHL2300309 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2023/12/09Import · Class 1 SAR441566 · No verified English nameJXHL2300308 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2023/12/09Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2303423 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/12/09Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303422 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/12/09Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2303414 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Indobufen TabletsCYHS2303413 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Magnesium Sulfate InjectionCYHS2303410 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2303409 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/12/09Generic · Class 3 Minoxidil LinimentCYHS2303407 Liaoning Xin Gao Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Pregabalin Extended release TabletsCYHS2303406 Zhejiang Nord Pharmaceutical Co., Ltd
2023/12/09Generic · Class 3 Pregabalin Extended release TabletsCYHS2303405 Zhejiang Nord Pharmaceutical Co., Ltd
2023/12/09Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303404 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2023/12/09Generic · Class 3 Minoxidil Topical SolutionCYHS2303403 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Minoxidil Topical SolutionCYHS2303402 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 Methocarbamol InjectionCYHS2303401 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/12/09Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300149 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized
2023/12/09New drug · Class 2.3 克感利咽口服液 · No verified English nameCXZL2300073 Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized
2023/12/09New drug · Class 1 注射用SKB264 · No verified English nameCXSS2300093 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/12/09New drug · Class 1 注射用SIBP-A17 · No verified English nameCXSL2300851 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/12/09New drug · Class 2.4 艾诺米替片 · No verified English nameCXHS2300112 Jiangsu Ai Di Pharma Co., Ltd. romanized
2023/12/09New drug · Class 2.4 艾诺韦林片 · No verified English nameCXHS2300111 Jiangsu Ai Di Pharma Co., Ltd. romanized
2023/12/09New drug · Class 1 BY101298胶囊 · No verified English nameCXHL2301366 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/09New drug · Class 1 BY101298胶囊 · No verified English nameCXHL2301365 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/09New drug · Class 1 BEBT-109胶囊 · No verified English nameCXHL2301364 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2023/12/09New drug · Class 1 BEBT-109胶囊 · No verified English nameCXHL2301363 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2023/12/09New drug · Class 1 GLB-001胶囊 · No verified English nameCXHL2301362 Hangzhou Ge Bo Biopharmaceuticals Co., Ltd. romanized

86 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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