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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 288 drug applications between 5 April 2023 and 11 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 50 drug names.

2023/04/05 – 2023/04/11

Period
2023/04/05 to 2023/04/11, 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
288
Drugs with new generic filings (by drug name, de-duplicated)
50
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

288filings, 71 of them generic

By application type

Application typeFilings
Supplement164
Generic71
New drug33
Import8
Unspecified6
Import re-registration5
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug219
Therapeutic biologic49
TCM18
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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets515
2氧(液态) · No verified English name2213
3Polyvinyl Alcohol Eye Drops2224
4Tadalafil Tablets2123
5Everolimus Tablets212
6Ozagrel Sodium Injection213
7Levocarnitine Oral Solution219
8Ibuprofen Injection218
9Torsemide Injection211
10Potassium Chloride Granules214

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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized35320
2Luye Pharma Limited710
3Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized660
4Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized520
5Organon Pharma (UK) Limited510
6Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized515
7Beijing Han Mei Medicines Co., Ltd. romanized443
8Qilu Pharmaceutical Co., Ltd.420
9Guangdong Dong Yang Guang Pharma Co., Ltd. romanized410
10Zhejiang Hang Kang 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

73 this week

AcceptedDrugApplicants
2023/04/11Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2300030 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/04/11Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSS2300029 Revance Therapeutics Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/04/11Import · Class 1 AZD4573 · No verified English nameJXHL2300076 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/04/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300018 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300017 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/11New drug · Class 1 IM83嵌合抗原受体T细胞注射液(IM83 CAR-T细胞注射液) · No verified English nameCXSL2300249 Beijing Yi Miao Shen Zhou Pharmaceuticals Technology Co., Ltd. romanized
2023/04/11New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300248 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/04/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2300247 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2300246 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/11New drug · Class 2.4 Sivelestat Sodium for InjectionCXHL2300361 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2023/04/10Generic · Class 3 Ibuprofen InjectionCYHS2301016 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/04/10Generic · Class 3 Ibuprofen InjectionCYHS2301015 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/04/10Generic · Class 3 依折麦布瑞舒伐他汀钙片(Ⅲ) · No verified English nameCYHS2301014 Beijing Han Mei Medicines Co., Ltd. romanized
2023/04/10Generic · Class 3 依折麦布瑞舒伐他汀钙片(Ⅱ) · No verified English nameCYHS2301013 Beijing Han Mei Medicines Co., Ltd. romanized
2023/04/10Generic · Class 3 依折麦布瑞舒伐他汀钙片(Ⅰ) · No verified English nameCYHS2301012 Beijing Han Mei Medicines Co., Ltd. romanized
2023/04/10Generic · Class 3 Torsemide InjectionCYHS2301009 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Torsemide InjectionCYHS2301008 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Ferrous Succinate TabletsCYHS2301006 Beijing Foyou Pharma CO.,LTD
2023/04/10Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301005 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/04/10Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301004 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/04/10Generic · Class 3 Progesterone InjectionCYHS2301003 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/04/10Generic · Class 3 Pentoxifylline InjectionCYHS2301000 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2300998 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300052 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300051 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300050 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300049 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300048 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized
2023/04/10Generic · Class 3 Alprostadil InjectionCYHL2300047 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/10Generic · Class 3 Colesevelam Hydrochloride TabletsCYHL2300046 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.

43 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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