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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 17 June 2022 and 23 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.

2022/06/17 – 2022/06/23

Period
2022/06/17 to 2022/06/23, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
32
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

301filings, 43 of them generic

By application type

Application typeFilings
Supplement163
Generic43
New drug40
Import25
Unspecified15
Import re-registration15

By drug type

Drug typeFilings
Chemical drug198
TCM49
Therapeutic biologic42
Biologic9
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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets3220
2Venlafaxine Hydrochloride Sustained-Release Capsules310
3Elagolix Tablets212
4Vonoprazan Fumarate Tablets2160
5Levetiracetam Tablets216
6Aminocaproic Acid Injection210
7Minoxidil Liniment2152
8阿普米司特片 · No verified English name213
9Aprepitant Capsules210
10Linagliptin Tablets112

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized19150
2Henan Tong Yuan Pharmaceutical Co., Ltd. romanized990
3Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized770
4Aspen Pharma Trading Limited720
5Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized660
6Janssen Research & Development LLC530
7The Wellcome Foundation Limited510
8GlaxoSmithKline Biologicals SA440
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
10Chengdu Brilliant Pharmaceutical Co., Ltd.422

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

80 this week

AcceptedDrugApplicants
2022/06/23Import · Class 3.1 注射用Teduglutide · No verified English nameJXSS2200021 Takeda Pharmaceuticals International AG Ireland Branch; Patheon Italia S.p.A.
2022/06/23Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2200094 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/06/23Import · Class 1 BI 764198胶囊 · No verified English nameJXHL2200161 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 1 BI 764198胶囊 · No verified English nameJXHL2200160 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 1 BI 764198胶囊 · No verified English nameJXHL2200159 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/23Import · Class 2.4 Belzutifan片 · No verified English nameJXHL2200158 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2022/06/23Generic · Class 3 Carglumic Acid Dispersible TabletsCYHS2200940 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2022/06/23Generic · Class 3 Furosemide Oral SolutionCYHS2200938 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2022/06/23Generic · Class 3 Citicoline Sodium InjectionCYHS2200933 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/06/23Generic · Class 3 维A酸软胶囊 · No verified English nameCYHS2200932 Shandong Liang Fu Pharmaceutical Co., Ltd. romanized
2022/06/23New drug · Class 1 LM-102注射液 · No verified English nameCXSL2200290 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2022/06/23New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2200289 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2022/06/23New drug · Class 1 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2200288 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2022/06/23New drug · Class 2.2 恩沃利单抗注射液 · No verified English nameCXSL2200287 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2022/06/23New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2200286 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/06/23New drug · Class 1 JX7002注射液 · No verified English nameCXSL2200264 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/06/23New drug · Class 1 TQ-B3101胶囊 · No verified English nameCXHS2200035 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/06/23New drug · Class 1 TQ-B3101胶囊 · No verified English nameCXHS2200034 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/06/23New drug · Class 1 MN-08片 · No verified English nameCXHL2200413 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/06/23New drug · Class 1 WXSH0208片 · No verified English nameCXHL2200412 CISEN PHARMACEUTICAL CO., LTD.
2022/06/23New drug · Class 1 WXSH0208片 · No verified English nameCXHL2200411 CISEN PHARMACEUTICAL CO., LTD.
2022/06/23New drug · Class 2.2 注射用SAK2001 · No verified English nameCXHL2200410 Hui Yu Kang Cheng (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized
2022/06/23New drug · Class 1 NH300094片 · No verified English nameCXHL2200409 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/06/23New drug · Class 1 NH300094片 · No verified English nameCXHL2200408 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/06/23New drug · Class 1 NH300094片 · No verified English nameCXHL2200407 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2022/06/23New drug · Class 2.1 MBT-1316片 · No verified English nameCXHL2200406 Beijing Jun Ke Hua Yuan Pharmaceuticals Technology Co., Ltd. romanized
2022/06/22Import · Class 1 Imsidolimab注射液 · No verified English nameJXSL2200093 AnaptysBio Inc.; PPC China Corporation Limited
2022/06/22Import · Class 2.4 Setmelanotide注射液 · No verified English nameJXHL2200156 Rhythm Pharmaceuticals; Citrine Medicine (Shanghai) Co. Ltd
2022/06/22Import · Class 1 KIN-2787片 · No verified English nameJXHL2200154 Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd.
2022/06/22Import · Class 1 KIN-2787片 · No verified English nameJXHL2200153 Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd.

50 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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