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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 13 June 2024 and 19 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 60 drug names.

2024/06/13 – 2024/06/19

Period
2024/06/13 to 2024/06/19, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
3

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

323filings, 77 of them generic

By application type

Application typeFilings
Supplement175
Generic77
New drug49
Import11
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug210
TCM60
Therapeutic biologic42
Prophylactic biologic9
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection512
2Levocarnitine Oral Solution339
3Brivaracetam Tablets3119
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets2212
5Tacrolimus Capsules212
6头孢呋辛酯干混悬剂 · No verified English name215
7Bisoprolol Fumarate Tablets216
8Ibuprofen Suspension2114
9Cariprazine hydrochloride Capsules213
10Amikacin Sulfate injection214

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging S.P.A.2410
2Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized1080
3Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized872
4Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized740
5Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized720
6Boehringer Ingelheim International GmbH710
7Novartis Pharma Schweiz AG530
8CISEN PHARMACEUTICAL CO., LTD.533
9Xizang Jin Yue Pharmaceuticals Co., Ltd. romanized515
10Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma 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

98 this week

AcceptedDrugApplicants
2024/06/19Import · Class 2.4 奥贝胆酸(OCA) · No verified English nameJXHL2400144 Intercept Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/06/19Import · Class 2.4 奥贝胆酸(OCA) · No verified English nameJXHL2400143 Intercept Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/06/19Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2401833 Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2024/06/19Generic · Class 3 Latamoxef Sodium for InjectionCYHS2401826 Shandong Yi He Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2024/06/19Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2401825 Chengdu Pusch Pharmaceutical Co., Ltd.
2024/06/19Generic · Class 3 Brivaracetam TabletsCYHL2400118 CISEN PHARMACEUTICAL CO., LTD.
2024/06/19Generic · Class 3 Brivaracetam TabletsCYHL2400117 CISEN PHARMACEUTICAL CO., LTD.
2024/06/19Generic · Class 3 Brivaracetam TabletsCYHL2400116 CISEN PHARMACEUTICAL CO., LTD.
2024/06/19Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2400115 Wuhan Ren Fu Pharma Co., Ltd. romanized
2024/06/19Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2400114 Wuhan Ren Fu Pharma Co., Ltd. romanized
2024/06/19New drug · Class 1 VUM02注射液 · No verified English nameCXSL2400401 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2024/06/19New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2400400 Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized
2024/06/19New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2400399 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2024/06/19New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2400398 Suzhou Di Xin Chen Ke Bio Technology Co., Ltd. romanized
2024/06/19New drug · Class 2.2 HCD干混悬剂 · No verified English nameCXHL2400612 Zhejiang Sheng Bo Kang Pharma Co., Ltd. romanized
2024/06/19New drug · Class 1 HRS9950片 · No verified English nameCXHL2400611 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/06/19New drug · Class 1 HRS9950片 · No verified English nameCXHL2400610 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/06/18Import · Class 1 BRII-179注射液 · No verified English nameJXSL2400115 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/06/18Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2400114 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2024/06/18Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2400142 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2024/06/18Generic · Class 3 Trimebutine Maleate TabletsCYHS2401822 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2024/06/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401819 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2024/06/18Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401815 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/06/18Generic · Class 3 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHS2401813 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2024/06/18Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401812 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2024/06/18Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2401811 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/06/18Generic · Class 3 Deoxycholic Acid InjectionCYHL2400113 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/06/18New drug · Class 2.3 白脉软膏 · No verified English nameCXZL2400034 Xizang Qi Zheng Zang Yao Co., Ltd. romanized
2024/06/18New drug · Class 3.2 注射用重组人促甲状腺激素 · No verified English nameCXSS2400060 Name not romanized
2024/06/18New drug · Class 1 HRS-5635注射液 · No verified English nameCXHL2400609 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized

68 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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