YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 106 drug applications between 24 January 2023 and 30 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 29 drug names.

2023/01/24 – 2023/01/30

Period
2023/01/24 to 2023/01/30, 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
106
Drugs with new generic filings (by drug name, de-duplicated)
29
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

106filings, 33 of them generic

By application type

Application typeFilings
Supplement37
Generic33
New drug28
Import re-registration6
Import2

By drug type

Drug typeFilings
Chemical drug86
Therapeutic biologic12
TCM5
Prophylactic biologic3

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

29 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olaparib Tablets210
2Levocarnitine Injection214
3Amisulpride Injection211
4Potassium Chloride Granules214
5Epalrestat Tablets111
6Diclofenac Sodium Enteric-coated Tablets112
7吉非替尼片 · No verified English name111
8地氯雷他定口服溶液 · No verified English name1126
9Doxofylline Injection115
10Olmesartan Medoxomil and Hydrochlorothiazide Tablets113

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

79 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
2Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
3Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized320
4Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized310
5Hainan Huluwa Pharmaceutical Group Co., Ltd.222
6Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized220
7A. Menarini GmbH210
8Kyowa Kirin Co. Ltd.210
9Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized212
10Haerbin Song He Pharmaceutical Co., Ltd. romanized212

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

45 this week

AcceptedDrugApplicants
2023/01/30Import · Class 1 碘[131I]-IPA注射液 · No verified English nameJXHL2300014 Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd.
2023/01/30Generic · Class 3 Carbocisteine Oral SolutionCYHS2300247 Jian Min Pharma Group Co., Ltd. romanized
2023/01/30Generic · Class 3 Entecavir oral solutionCYHS2300245 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2023/01/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2300240 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2023/01/30Generic · Class 3 Amisulpride InjectionCYHL2300011 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/30Generic · Class 3 Amisulpride InjectionCYHL2300010 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/30New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2300124 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2023/01/30New drug · Class 2.2 孟鲁司特钠凝胶 · No verified English nameCXHL2300123 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2023/01/30New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2300122 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2023/01/30New drug · Class 1 P29注射液 · No verified English nameCXHL2300121 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2023/01/29Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2300236 Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized
2023/01/29Generic · Class 3 布洛芬混悬滴剂 · No verified English nameCYHS2300235 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2023/01/29Generic · Class 3 Famotidine InjectionCYHS2300234 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/01/29Generic · Class 3 Oxytocin InjectionCYHS2300230 Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2023/01/29Generic · Class 3 Potassium Chloride GranulesCYHS2300228 Zhuhai Shi Hui Tong Da Pharmaceuticals Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/01/29Generic · Class 3 Potassium Chloride GranulesCYHS2300227 Zhuhai Shi Hui Tong Da Pharmaceuticals Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/01/29Generic · Class 3 Indocyaninegreen for InjectionCYHS2300225 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/01/29Generic · Class 3 Epalrestat TabletsCYHS2300224 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/01/29Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2300009 Yuan Zi Gao Ke Co., Ltd. romanized
2023/01/29Generic · Class 3 Flurbiprofen PatchesCYHL2300008 Hunan Jiudian Pharmaceutical Co., Ltd
2023/01/29New drug · Class 3.3 雷珠单抗注射液 · No verified English nameCXSS2300004 Qilu Pharmaceutical Co., Ltd.
2023/01/29New drug · Class 1 注射用RC118 · No verified English nameCXSL2300065 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/29New drug · Class 1 CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300064 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/01/29New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2300063 Beijing Min Hai Bio Technology Co., Ltd. romanized
2023/01/29New drug · Class 1 盐酸佐利替尼片 · No verified English nameCXHS2300020 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/29New drug · Class 1 盐酸佐利替尼片 · No verified English nameCXHS2300019 Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/29New drug · Class 1 HSK7653片 · No verified English nameCXHS2300018 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/01/29New drug · Class 1 HSK7653片 · No verified English nameCXHS2300017 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/01/29New drug · Class 1 SPH4336片 · No verified English nameCXHL2300120 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/01/29New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2300119 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

15 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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