YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 63 drug applications between 23 January 2023 and 29 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 18 drug names.

2023/01/23 – 2023/01/29

Period
2023/01/23 to 2023/01/29, 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
63
Drugs with new generic filings (by drug name, de-duplicated)
18
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

63filings, 19 of them generic

By application type

Application typeFilings
New drug24
Generic19
Supplement13
Import re-registration6
Import1

By drug type

Drug typeFilings
Chemical drug47
Therapeutic biologic11
TCM4
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules214
2Epalrestat Tablets111
3Diclofenac Sodium Enteric-coated Tablets112
4吉非替尼片 · No verified English name111
5Tenofovir alafenamide Fumarate Tablets110
6布南色林片 · No verified English name110
7布洛芬混悬滴剂 · No verified English name110
8氟比洛芬凝胶贴膏 · No verified English name1116
9Flurbiprofen Patches111
10Famotidine Injection118

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

50 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD410
2Hainan Huluwa Pharmaceutical Group Co., Ltd.222
3Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized220
4A. Menarini GmbH210
5Kyowa Kirin Co. Ltd.210
6TIANJIN LISHENG PHARMACEUTICAL CO., LTD210
7Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized210
8Hai Chuang Pharma Co., Ltd. romanized210
9Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized210
10Zhuhai Shi Hui Tong Da Pharmaceuticals 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

35 this week

AcceptedDrugApplicants
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
2023/01/29New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2300118 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/29New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2300117 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/29New drug · Class 1 HP501缓释片 · No verified English nameCXHL2300116 Hai Chuang Pharma Co., Ltd. romanized
2023/01/29New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2300115 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/29New drug · Class 1 HP501缓释片 · No verified English nameCXHL2300114 Hai Chuang Pharma Co., Ltd. romanized
2023/01/28Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2300013 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/01/28New drug · Class 3.1 枇杷清肺颗粒 · No verified English nameCXZS2300004 Jilin Ao Dong Tao Nan Pharma Co., Ltd. romanized
2023/01/28New drug · Class 2.2 小儿豉翘清热糖浆 · No verified English nameCXZS2300003 Ji Chuan Pharma Group Co., Ltd. romanized
2023/01/28New drug · Class 1.1 杞菊颗粒 · No verified English nameCXZL2300004 Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized
2023/01/28New drug · Class 1 JAB-BX300注射液 · No verified English nameCXSL2300062 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized

5 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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