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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 348 drug applications between 23 July 2024 and 29 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.

2024/07/23 – 2024/07/29

Period
2024/07/23 to 2024/07/29, 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
348
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
4

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

348filings, 93 of them generic

By application type

Application typeFilings
Supplement161
Generic93
New drug56
Unspecified22
Import10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug241
TCM55
Therapeutic biologic38
Biologic10
Prophylactic biologic4

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets8331
2Flumazenil Injection312
3地氯雷他定口服溶液 · No verified English name2226
4Pranoprofen Eye Drops227
5Isavuconazonium Sulfate for Injection2215
6Lurasidone Hydrochloride Tablets222
7维生素B6注射液 · No verified English name2210
8Dapagliflozin Tablets2284
9Bromhexine Hydrochloride Solution For Inhalation211
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1170
2Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized910
3Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized660
4Shandong Lv Ye Pharmaceutical Co., Ltd. romanized610
5Pfizer Inc.520
6Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized444
7Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized440
8AstraZeneca AB430
9Baxter Deutschland GmbH430
10Beijing Tai De Pharmaceutical 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

95 this week

AcceptedDrugApplicants
2024/07/29New drug · Class 1.4 流感病毒亚单位疫苗(佐剂) · No verified English nameCXSL2400493 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2024/07/29New drug · Class 1 NK510细胞注射液 · No verified English nameCXSL2400492 Shanghai Bei Si Ang Ke Bio Technology Co., Ltd. romanized; Zhuhai Bei Si Ang Ke Technology Co., Ltd. romanized
2024/07/27Import · Class 2.2 阿替利珠单抗注射液(皮下注射) · No verified English nameJXSS2400064 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2024/07/27Import · Class 3.1 阿替利珠单抗注射液(皮下注射) · No verified English nameJXSS2400063 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2024/07/27Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402382 Zhejiang Nord Pharmaceutical Co., Ltd
2024/07/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402380 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/07/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402378 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/07/27Generic · Class 3 Epalrestat TabletsCYHS2402372 Ningxia Kang Ya Pharma Co., Ltd. romanized
2024/07/27New drug · Class 1.2 ZY13提取物 · No verified English nameCXZL2400043 Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 1.2 ZY13片 · No verified English nameCXZL2400042 Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 1.1 通塞颗粒 · No verified English nameCXZL2400041 Henan Zhong Pharmaceuticals University romanized
2024/07/27New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSS2400080 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2024/07/27New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2400491 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2400490 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2400489 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2400488 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400487 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 1 SHR-6934注射液 · No verified English nameCXSL2400486 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized
2024/07/27New drug · Class 1.3 四价流感病毒裂解疫苗(ZFA02佐剂) · No verified English nameCXSL2400485 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2400484 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/07/27New drug · Class 1 注射用AK138D1 · No verified English nameCXSL2400483 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2024/07/27New drug · Class 1 POV-601-1A1溶瘤病毒注射液 · No verified English nameCXSL2400482 Suzhou Bo Re Bio Technology Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400066 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400065 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400064 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400063 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400062 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 2.2 棕榈酸帕利哌酮注射液(II) · No verified English nameCXHS2400061 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/07/27New drug · Class 1 GTA182片 · No verified English nameCXHL2400763 Shanghai Pai Long Bio Technology Co., Ltd. romanized
2024/07/27New drug · Class 1 GTA182片 · No verified English nameCXHL2400762 Shanghai Pai Long Bio Technology Co., Ltd. romanized

65 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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