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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 306 drug applications between 22 May 2024 and 28 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 66 drug names.

2024/05/22 – 2024/05/28

Period
2024/05/22 to 2024/05/28, 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
306
Drugs with new generic filings (by drug name, de-duplicated)
66
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

306filings, 80 of them generic

By application type

Application typeFilings
Supplement147
Generic80
New drug38
Import19
Import re-registration17
Unspecified5

By drug type

Drug typeFilings
Chemical drug195
TCM60
Therapeutic biologic46
Prophylactic biologic4
Biologic1

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bupivacaine Hydrochloride Injection424
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
3Lactulose Oral Solution2134
4复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English name210
5Nicergoline Tablets211
6Baricitinib Tablets2132
7平衡盐冲洗液 · No verified English name210
8Famotidine Injection218
9注射用头孢唑肟钠 · No verified English name214
10Isoprenaline Hydrochloride Injection217

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHEPLAPHARM Registration GmbH720
2Qin Huang Dao Shan Hai Guan Pharma Co., Ltd. romanized660
3Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
4Eli Lilly and Company610
5Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
6Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized540
7AbbVie Inc.530
8Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized520
9Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized440
10Henan Hua Feng Pharmaceutical Co., Ltd. romanized440

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

94 this week

AcceptedDrugApplicants
2024/05/28Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2400104 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400123 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400122 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400121 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400120 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400119 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400118 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2401595 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/05/28Generic · Class 3 Ibuprofen TabletsCYHS2401594 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2024/05/28Generic · Class 3 Potassium Chloride InjectionCYHS2401593 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized; Hubei Ke Lun Pharma Co., Ltd. romanized
2024/05/28Generic · Class 3 多索茶碱糖浆 · No verified English nameCYHS2401592 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/05/28Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2401584 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2024/05/28New drug · Class 1.1 参蒲盆安颗粒 · No verified English nameCXZS2400017 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/05/28New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2400054 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/05/28New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2400053 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/05/28New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2400052 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/05/28New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2400051 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/05/28New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400350 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2024/05/27Import · Class 2.4 盐酸非苏拉生片 · No verified English nameJXHL2400117 Daewoong Pharmaceutical Co. Ltd.; Yangtze River Pharmaceutical Group Shanghai Haini Pharmceutical Co. Ltd.
2024/05/27Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2401579 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/05/27Generic · Class 3 Brivaracetam Oral SolutionCYHS2401578 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2024/05/25Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401573 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/05/25Generic · Class 3 Acetylcysteine InjectionCYHS2401572 Hubei Jin Yao Pharma Co., Ltd. romanized
2024/05/25New drug · Class 1 LY01620 · No verified English nameCXSL2400349 Nanjing Ji Mai Bio Technology Co., Ltd. romanized
2024/05/25New drug · Class 1 注射用ZGGS18 · No verified English nameCXSL2400348 Name not romanized
2024/05/25New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400347 Name not romanized
2024/05/25New drug · Class 1 RC148注射液 · No verified English nameCXSL2400346 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/25New drug · Class 1 注射用RC118 · No verified English nameCXSL2400345 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/25New drug · Class 2.4 青蒿琥酯片 · No verified English nameCXHL2400527 Gui Lin Nan Yao Co., Ltd. romanized; Shanghai Jiao Tong University romanized
2024/05/24Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2400103 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.

64 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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