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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 255 drug applications between 25 May 2022 and 31 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 35 drug names.

2022/05/25 – 2022/05/31

Period
2022/05/25 to 2022/05/31, 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
255
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
1

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

255filings, 53 of them generic

By application type

Application typeFilings
Supplement116
Generic53
New drug46
Import19
Unspecified14
Import re-registration7

By drug type

Drug typeFilings
Chemical drug177
Therapeutic biologic39
TCM30
Biologic7
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
2Palbociclib Capsules310
3阿普米司特片 · No verified English name313
4Epalrestat Tablets221
5Tadalafil Tablets2123
6Irbesartan and Amlodipine Tablets211
7Ornidazole Injection210
8Paliperidone Extend-release Tablets212
9Lamotrigine Dispersible Tablets212
10Dopamine Hydrochloride Injection213

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

153 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Yuan Dong Pharma Co., Ltd. romanized660
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized540
3Novartis Pharma AG530
4Hainan Zan Bang Pharmaceutical Co., Ltd. romanized520
5ASPEN PHARMA TRADING LIMITED510
6Shandong Xin Shi Dai Pharma Co., Ltd. romanized331
7Ren He Yi Kang Group Co., Ltd. romanized320
8Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized320
9Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized321
10Qilu Pharmaceutical (Hainan) Co., Ltd321

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
2022/05/31Import · 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.
2022/05/28Import · Class 1 Enpatoran · No verified English nameJXHL2200121 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/05/28Generic · Class 3 Epalrestat TabletsCYHS2200799 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/05/28New drug · Class 1 伊基仑赛注射液 · No verified English nameCXSL2200234 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2022/05/28New drug · Class 1 伊基仑赛注射液 · No verified English nameCXSL2200233 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2022/05/28New drug · Class 1 EOC202注射液 · No verified English nameCXSL2200232 Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized
2022/05/28New drug · Class 2.2 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2200341 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2022/05/28New drug · Class 2.2 Enzalutamide TabletsCXHL2200339 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized
2022/05/27Import · Class 3.1 司美格鲁肽片 · No verified English nameJXSS2200018 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. 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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