YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 316 drug applications between 21 October 2023 and 27 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 80 drug names.

2023/10/21 – 2023/10/27

Period
2023/10/21 to 2023/10/27, 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
316
Drugs with new generic filings (by drug name, de-duplicated)
80
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

316filings, 103 of them generic

By application type

Application typeFilings
Supplement138
Generic103
New drug55
Import9
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug230
TCM54
Therapeutic biologic26
Biologic4
Prophylactic biologic2

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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate For Oral Suspension322
2Acetylcysteine Oral Solution3111
3Nicardipine Hydrochloride Injection3113
4Sodium Valproate Sustained-release Tablets(I)224
5Olanzapine Tablets214
6Vonoprazan Fumarate Tablets2160
7Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
8Tolvaptan Orally Disintegrating Tablets215
9Torsemide Injection211
10Lacosamide Tablets210

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

202 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized15140
2Hebei Yu Zhi Lin Pharma Co., Ltd. romanized880
3YaoPharma Co., Ltd.543
4Jin He Zang Yao Co., Ltd. romanized540
5Li Bang Pharma (Shanghai) Co., Ltd. romanized510
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD434
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
8TRUEMED LTD.410
9Takeda Manufacturing Austria AG410
10Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized410

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

105 this week

AcceptedDrugApplicants
2023/10/27Import · Class 1 DS-6000a · No verified English nameJXSL2300189 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2023/10/27Generic · Class 3 盐酸拉贝洛尔氯化钠注射液 · No verified English nameCYHS2302925 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/10/27Generic · Class 3 Milrinone InjectionCYHS2302916 Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2023/10/27Generic · Class 3 Milrinone InjectionCYHS2302915 Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2023/10/27New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2300734 Kang Fang Pharma Co., Ltd. romanized
2023/10/27New drug · Class 1 AK127注射液 · No verified English nameCXSL2300733 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/10/27New drug · Class 2.2 HJE-219 · No verified English nameCXHL2301173 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/27New drug · Class 1 AND019·MSA胶囊 · No verified English nameCXHL2301172 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/10/27New drug · Class 1 AND019·MSA胶囊 · No verified English nameCXHL2301171 Hangzhou An Dao Pharma Co., Ltd. romanized
2023/10/26Import · Class 2.2 埃万妥单抗注射液 · No verified English nameJXSS2300080 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.
2023/10/26Import · Class 3.1 索米妥昔单抗注射液 · No verified English nameJXSS2300079 ImmunoGen Inc.; BSP Pharmaceuticals S.p.A.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD.
2023/10/26Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302914 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2023/10/26Generic · Class 3 Thioctic Acid TabletsCYHS2302913 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/10/26Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2302911 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/10/26Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302907 Hubei Kai An Chen Pharmaceuticals Technology Co., Ltd. romanized; Hubei Guang Ren Pharma Co., Ltd. romanized
2023/10/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2302905 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2023/10/26New drug · Class 1 LY-M001注射液 · No verified English nameCXSL2300730 Ling Yi (Hangzhou) Bio Technology Co., Ltd. romanized
2023/10/26New drug · Class 1 AK120注射液 · No verified English nameCXSL2300729 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/10/26New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300728 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2023/10/26New drug · Class 1 EP-0146片 · No verified English nameCXHL2301170 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/10/26New drug · Class 1 EP-0146片 · No verified English nameCXHL2301169 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/10/26New drug · Class 1 EP-0146片 · No verified English nameCXHL2301168 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/10/26New drug · Class 1 AP303片 · No verified English nameCXHL2301167 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2023/10/26New drug · Class 1 AP303片 · No verified English nameCXHL2301166 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2023/10/26New drug · Class 1 AP303片 · No verified English nameCXHL2301165 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2023/10/26New drug · Class 1 AP303片 · No verified English nameCXHL2301164 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2023/10/26New drug · Class 1 AP303片 · No verified English nameCXHL2301163 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2023/10/26New drug · Class 1 艾托莫德片 · No verified English nameCXHL2301162 Jian Kuan (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized
2023/10/25Import · Class 1 BMS-986435片 · No verified English nameJXHL2300267 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/10/25Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2302896 Rui Yang Pharmaceutical Co., Ltd. romanized

75 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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