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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 27 May 2022 and 2 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 39 drug names.

2022/05/27 – 2022/06/02

Period
2022/05/27 to 2022/06/02, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
3

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

279filings, 57 of them generic

By application type

Application typeFilings
Supplement149
Generic57
New drug36
Unspecified15
Import13
Import re-registration9

By drug type

Drug typeFilings
Chemical drug186
TCM49
Therapeutic biologic35
Biologic6
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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
2阿普米司特片 · No verified English name313
3Epalrestat Tablets221
4Lacosamide Injection220
5Calcium Gluconate in Sodium Chloride Injection225
6Tadalafil Tablets2123
7Irbesartan and Amlodipine Tablets211
8Ornidazole Injection210
9Levetiracetam Tablets216
10Paliperidone Extend-release Tablets212

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

163 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Yu Gang Pharmaceutical Co., Ltd. romanized14130
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
3Jiangxi Yuan Dong Pharma Co., Ltd. romanized660
4Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized440
5Novartis Pharma AG430
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized420
7Jilin Rui Long Pharma Co., Ltd. romanized330
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized331
9Guangxi Ji Min Tang Pharma Co., Ltd. romanized330
10Yi Chang Ren Fu Pharma Co., Ltd. romanized320

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

64 this week

AcceptedDrugApplicants
2022/06/02New drug · Class 1 QY201片 · No verified English nameCXHL2200349 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/02New drug · Class 1 QY201片 · No verified English nameCXHL2200348 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/01Generic · Class 3 Peramivir InjectionCYHS2200819 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2022/06/01Generic · Class 3 Folic Acid TabletsCYHS2200810 Guangzhou Lang Sheng Pharma Co., Ltd. romanized
2022/06/01Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2200792 Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Hubei Hua Ren Tong Ji Pharma Co., Ltd. romanized
2022/06/01Generic · Class 3 Milrinone InjectionCYHS2200650 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2022/06/01New drug · Class 1 EMB-01注射液 · No verified English nameCXSL2200238 Shanghai An Mai Bio Technology Co., Ltd. romanized; An Mai Bio Technology (Suzhou) Co., Ltd. romanized
2022/06/01New drug · Class 1 安脑三醇注射液 · No verified English nameCXHL2200347 Guangzhou Shi Sai Pu Te Pharmaceuticals Technology Co., Ltd. romanized
2022/05/31Import · Class 2.4 Ibrutinib CapsulesJXHS2200052 Janssen-Cilag International NV; Catalent CTS LLC; Xian-Janssen Pharmaceutical Ltd.
2022/05/31Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2200815 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2022/05/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200814 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2022/05/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200813 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2022/05/31Generic · Class 3 Citicoline Sodium InjectionCYHS2200806 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2022/05/31Generic · Class 3 Citicoline Sodium InjectionCYHS2200805 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2022/05/31Generic · Class 3 Ornidazole InjectionCYHS2200779 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2022/05/31Generic · Class 3 Ornidazole InjectionCYHS2200778 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2022/05/31New drug · Class 2.3 前列闭尔通栓 · No verified English nameCXZL2200025 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 伊立珠单抗注射液 · No verified English nameCXSL2200237 Bai Tai Bio Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 BRL-101自体造血干祖细胞注射液 · No verified English nameCXSL2200236 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2022/05/31New drug · Class 1 IMB071703注射液 · No verified English nameCXSL2200235 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2022/05/31New drug · Class 1 洛奈利单抗注射液 · No verified English nameCXSL2200228 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 注射用Zilovertamab vedotin · No verified English nameCXSL2200227 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2022/05/31New drug · Class 2.2 醋酸阿比特龙片(Ⅰ) · No verified English nameCXHS2200030 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/31New drug · Class 1 SAL0112片 · No verified English nameCXHL2200344 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 SAL0112片 · No verified English nameCXHL2200343 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 SAL0112片 · No verified English nameCXHL2200342 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/05/31New drug · Class 1 注射用Hemay181 · No verified English nameCXHL2200338 Gan Zhou He Mei Pharma Co., Ltd. romanized
2022/05/28Import · Class 3.1 Netakimab注射液 · No verified English nameJXSL2200066 Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/05/28Import · Class 2.2 二氟泼尼酯滴眼液 · No verified English nameJXHL2200123 SUN PHARMACEUTICAL INDUSTRIES LTD.
2022/05/28Import · Class 1 Enpatoran · No verified English nameJXHL2200122 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.

34 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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