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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 280 drug applications between 28 December 2023 and 3 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 60 drug names.

2023/12/28 – 2024/01/03

Period
2023/12/28 to 2024/01/03, 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
280
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
1

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

280filings, 74 of them generic

By application type

Application typeFilings
Supplement130
Generic74
New drug55
Import re-registration10
Import9
Unspecified2

By drug type

Drug typeFilings
Chemical drug207
TCM34
Therapeutic biologic34
Prophylactic biologic5

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
1注射用头孢唑肟钠 · No verified English name424
2Penicillin G Sodium For Injection412
3Levofloxacin Tablets227
4氧 · No verified English name2215
5Calcipotriol and Betamethasone Ointment211
6Dopamine Hydrochloride Injection213
7Thioctic Acid Tablets214
8Azilsartan Medoxomil Potassium Tablets2135
9Sitagliptin and Metformin Hydrochloride Extended-release Tablets2112
10Desmopressin Acetate Injection210

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

183 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized10100
2Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized544
3Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized532
4Boehringer Ingelheim International GmbH510
5Jilin San Jiu Jin Fu Kang Pharma Co., Ltd. romanized440
6Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized440
7Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized420
8Shandong Luo Xin Pharma Group Co., Ltd. romanized420
9Xizang Bang Chen Pharma Group Co., Ltd. romanized420
10Bayer AG410

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
2024/01/03Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400001 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/01/03Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400001 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2024/01/03Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400020 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/01/03Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2400019 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2024/01/03Generic · Class 3 Potassium Chloride GranulesCYHS2400018 Anhui Jia He Pharma Co., Ltd. romanized
2024/01/03Generic · Class 3 Peramivir InjectionCYHS2400009 Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2024/01/03Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2400008 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/01/03Generic · Class 3 Thioctic Acid TabletsCYHS2400003 Zhejiang Hua Yuan Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/03Generic · Class 3 Thioctic Acid TabletsCYHS2400002 Zhejiang Hua Yuan Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/03Generic · Class 3 Methylergonovine Maleate InjectionCYHL2400002 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2024/01/03Generic · Class 3 Olopatadine Hydrochloride Nasal SprayCYHL2400001 Ying Ke Rui (Heng Qin) Drug Research Institute Co., Ltd. romanized
2024/01/03New drug · Class 1 IBI129 · No verified English nameCXSL2400006 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/01/03New drug · Class 1 KQ-2003自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2400005 Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized
2024/01/03New drug · Class 2.2 伊基奥仑赛注射液 · No verified English nameCXSL2400004 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2024/01/03New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2400003 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/01/03New drug · Class 1 重组人糜蛋白酶 · No verified English nameCXSL2400002 Wuhan He Yuan Bio Technology Co., Ltd. romanized
2024/01/03New drug · Class 1 注射用SIM0500 · No verified English nameCXSL2400001 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2300095 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2023/12/30Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2300094 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2023/12/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2303686 Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303684 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303683 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2303682 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2303681 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2023/12/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2300101 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2300909 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 3HP-2827片 · No verified English nameCXHL2301485 Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 3HP-2827片 · No verified English nameCXHL2301484 Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 INV-1120胶囊 · No verified English nameCXHL2301483 Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 INV-1120胶囊 · No verified English nameCXHL2301482 Fo Shan Shi Yuan Li Bio Technology 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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