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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 25 February 2025 and 3 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 68 drug names.

2025/02/25 – 2025/03/03

Period
2025/02/25 to 2025/03/03, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
68
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

347filings, 83 of them generic

By application type

Application typeFilings
Supplement196
Generic83
New drug38
Import16
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug219
TCM83
Therapeutic biologic34
Prophylactic biologic6
Biologic4
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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2Oxaliplatin Injection314
3Bromhexine Hydrochloride Injection228
4Lactulose Oral Solution2134
5Ibrutinib Tablets210
6Procaterol Hydrochloride Solution for Inhalation212
7Cefuroxime Sodium for Injection218
8Lysine Acetylsalicylate For Injection218
9盐酸丙卡特罗吸入溶液 · No verified English name213
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized24220
2Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized1690
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1030
4Guizhou San Ren Tang Pharma Co., Ltd. romanized880
5Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized660
6Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized550
7Boehringer Ingelheim International GmbH540
8Heilongjiang Han Hong Pharma Co., Ltd. romanized440
9Chongqing Xi Er An Pharma Co., Ltd. romanized420
10Baxter Holding B.V.330

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

91 this week

AcceptedDrugApplicants
2025/03/03Generic · Class 3 醋酸地非法林注射液 · No verified English nameCYHS2500902 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/03/03Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2500901 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/03/03Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2500900 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/03Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2500899 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/03Generic · Class 3 Ursodeoxycholic Acid GranulesCYHS2500897 Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized
2025/03/03Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2500896 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2025/03/03Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2500895 Hubei Jin Yao Pharma Co., Ltd. romanized
2025/03/03Generic · Class 3 Relugolix TabletsCYHL2500055 Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized
2025/03/03New drug · Class 2.3 SMF-217 · No verified English nameCXHL2500233 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/03/01Import · Class 2.2 CHF5993-II · No verified English nameJXHL2500032 Chiesi Farmaceutici S.p.A.; Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd.
2025/03/01Generic · Class 3 Ibrutinib TabletsCYHS2500891 Chongqing Huapont Pharmaceutical Co., Ltd.
2025/03/01Generic · Class 3 Ibrutinib TabletsCYHS2500890 Chongqing Huapont Pharmaceutical Co., Ltd.
2025/03/01Generic · Class 3 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2500889 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2025/03/01Generic · Class 3 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2500888 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2025/03/01Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2500885 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/03/01New drug · Class 1 IMB071703注射液 · No verified English nameCXSL2500189 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2025/03/01New drug · Class 1 LBM801 · No verified English nameCXSL2500188 Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized
2025/03/01New drug · Class 1 注射用Neu-001 · No verified English nameCXHL2500232 Shen Zhan Pharmaceuticals (Shenzhen) Co., Ltd. romanized
2025/03/01New drug · Class 2.4 TAP-1503 乳膏 · No verified English nameCXHL2500231 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2025/02/28Generic · Class 3 Ferrous Succinate TabletsCYHS2500883 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 Bifonazole SolutionCYHS2500881 Tang Shan Hong Xing Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500880 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500879 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500878 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Oxaliplatin InjectionCYHS2500877 Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized
2025/02/28Generic · Class 3 Brivaracetam Oral SolutionCYHS2500876 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/02/28Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2500872 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/02/28Generic · Class 3 Metronidazole Vaginal GelCYHL2500053 Hua Kong Innovation (Beijing) Drug Research Institute Co., Ltd. romanized
2025/02/28New drug · Class 3.1 半夏泻心汤颗粒 · No verified English nameCXZS2500010 Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized
2025/02/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500187 Beijing Tuo Hua Wei Ye Bio Technology Co., Ltd. romanized

61 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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