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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 414 drug applications between 30 November 2024 and 6 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 137, covering 102 drug names.

2024/11/30 – 2024/12/06

Period
2024/11/30 to 2024/12/06, 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
414
Drugs with new generic filings (by drug name, de-duplicated)
102
Accepted this week, now under review
10

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

414filings, 137 of them generic

By application type

Application typeFilings
Supplement184
Generic137
New drug70
Import11
Unspecified7
Import re-registration4
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug283
TCM69
Therapeutic biologic53
Biologic5
Prophylactic biologic3
In vitro diagnostic reagent1

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

102 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution5134
2Ambroxol Hydrochloride Oral Solution4146
3Tadalafil Tablets3223
4Oxcarbazepine Extended-release Tablets310
5Procaterol Hydrochloride Granules312
6Polymyxin B sulfate for Injection226
7Isavuconazonium Sulfate for Injection2215
8Sodium Hyaluronate Eye Drops2230
9复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
10Vonoprazan Fumarate Tablets2160

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

253 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized13130
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
3SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED652
4Shandong Xin Shi Dai Pharma Co., Ltd. romanized620
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
6Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized555
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.545
8Ren He Yi Kang Group Co., Ltd. romanized522
9The Wellcome Foundation Limited510
10Shaanxi Xing Bang Pharma Co., Ltd. romanized515

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

131 this week

AcceptedDrugApplicants
2024/12/06Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404234 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/06Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404233 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/06Generic · Class 3 Progesterone InjectionCYHS2404227 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized
2024/12/06Generic · Class 3 Sodium Bicarbonate InjectionCYHS2404225 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Sodium Bicarbonate InjectionCYHS2404224 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Terbutaline Sulfate InjectionCYHS2404218 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized
2024/12/06Generic · Class 3 Indocyaninegreen for InjectionCYHS2404217 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Terbutaline Sulfate InjectionCYHS2404216 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized
2024/12/06Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2404207 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/12/06Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400248 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2024/12/06New drug · Class 1 IBI3002 · No verified English nameCXSL2400832 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/12/06New drug · Class 1 注射用SLN12140 · No verified English nameCXSL2400831 Ling Nuo (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/12/06New drug · Class 1 HX009注射液 · No verified English nameCXSL2400830 Hangzhou Han Si Biopharmaceuticals Co., Ltd. romanized
2024/12/06New drug · Class 1 SCTT11注射液 · No verified English nameCXSL2400829 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/12/06New drug · Class 1 注射用YL201 · No verified English nameCXSL2400828 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2024/12/06New drug · Class 1 KN060注射液 · No verified English nameCXSL2400827 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2024/12/06New drug · Class 2.2 LNH2116-X1 · No verified English nameCXHL2401326 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2024/12/06New drug · Class 1 康太替尼片 · No verified English nameCXHL2401325 Shou Yao Holding (Beijing) Co., Ltd. romanized
2024/12/06New drug · Class 1 康太替尼片 · No verified English nameCXHL2401324 Shou Yao Holding (Beijing) Co., Ltd. romanized
2024/12/06New drug · Class 1 SY-5933片 · No verified English nameCXHL2401323 Shou Yao Holding (Beijing) Co., Ltd. romanized
2024/12/06New drug · Class 1 XZP-7797-H1片 · No verified English nameCXHL2401322 Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized
2024/12/06New drug · Class 1 XZP-7797-H1片 · No verified English nameCXHL2401321 Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400286 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400285 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Import · Class 1 PF-07934040片 · No verified English nameJXHL2400284 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/12/05Generic · Class 3 多索茶碱口服溶液 · No verified English nameCYHS2404206 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/12/05Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2404201 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/12/05Generic · Class 3 Gabexate Mesilate For InjectionCYHS2404194 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/12/05Generic · Class 3 Oxcarbazepine Extended-release TabletsCYHL2400247 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2024/12/05Generic · Class 3 Oxcarbazepine Extended-release TabletsCYHL2400246 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized

101 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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