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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 419 drug applications between 27 August 2025 and 2 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 75 drug names.

2025/08/27 – 2025/09/02

Period
2025/08/27 to 2025/09/02, 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
419
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
107

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

419filings, 109 of them generic

By application type

Application typeFilings
Supplement176
Generic109
New drug88
Import32
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug281
TCM65
Therapeutic biologic63
Biologic8
Prophylactic 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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6270
2瑞维那新吸入溶液 · No verified English name3353
3Ozagrel Sodium Injection313
4Ambroxol Hydrochloride Injection319
5Glucosamine Sulfate Capsules2251
6Iguratimod Tablets2223
7Mupirocin Ointment2230
8Apalutamide Tablets2218
9Rivaroxaban Tablets213
10地氯雷他定口服溶液 · No verified English name2126

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

228 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized12110
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1080
3Eli Lilly and Company920
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
5Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized770
6Novo Nordisk A/S620
7AstraZeneca AB530
8Takeda Canada Inc510
9Terumo Corporation Kofu Factory510
10Qilu Pharmaceutical Co., Ltd.510

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

154 this week

AcceptedDrugApplicants
2025/09/02Import · Class 1 斯贝利单抗注射液 · No verified English nameJXSS2500118 Otsuka Pharmaceutical Co. Ltd.; Vetter Pharma-Fertigung GmbH & Co. KG; Otsuka Beijing Research Institute
2025/09/02Import · Class 2.2 本瑞利珠单抗注射液 · No verified English nameJXSS2500117 AstraZeneca AB; Name not romanized
2025/09/02Import · Class 2.2 本瑞利珠单抗注射液 · No verified English nameJXSS2500116 AstraZeneca AB; Name not romanized
2025/09/02Import · Class 2.1; 2.2 MK-3475A注射液 · No verified English nameJXSL2500166 Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd
2025/09/02Import · Class 2.1; 2.2 MK-3475A注射液 · No verified English nameJXSL2500165 Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd
2025/09/02Import · Class 1 MK-1084片 · No verified English nameJXHL2500252 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/02Import · Class 1 MK-1084片 · No verified English nameJXHL2500251 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/02Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2503243 CISEN PHARMACEUTICAL CO., LTD.
2025/09/02Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2503242 CISEN PHARMACEUTICAL CO., LTD.
2025/09/02Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2503235 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/09/02Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2503234 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/09/02Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2503232 Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2025/09/02Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2503231 Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2025/09/02Generic · Class 3 Ozagrel Sodium InjectionCYHS2503227 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2025/09/02Generic · Class 3 Ozagrel Sodium InjectionCYHS2503226 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2025/09/02Generic · Class 3 Ozagrel Sodium InjectionCYHS2503225 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2025/09/02Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2503221 Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/09/02Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2503220 Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/09/02Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2503219 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/09/02Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2503217 Jiangsu Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2025/09/02Generic · Class 3 Cyclophosphamide InjectionCYHS2503216 Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized
2025/09/02Generic · Class 3 Cyclophosphamide InjectionCYHS2503215 Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized
2025/09/02New drug · Class 1.1 芪苓颗粒 · No verified English nameCXZL2500071 Zheng Da Qing Chun Bao Pharma Co., Ltd. romanized
2025/09/02New drug · Class 1.1 小儿安神补脑颗粒 · No verified English nameCXZL2500070 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shenzhen Shi Zhong Hospital romanized; Shenzhen Shi Medicines Jian Yan Research Institute (Shenzhen Shi Medical Devices Jian Ce Center) romanized; Shenzhen Shi Zhong Yao Zhi Zao Ye Innovation Center Co., Ltd. romanized
2025/09/02New drug · Class 1.4 吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameCXSL2500756 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/09/02New drug · Class 1 BBM-C101注射液 · No verified English nameCXSL2500755 Shanghai Mian Yi Bio Technology Co., Ltd. romanized
2025/09/02New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500754 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/02New drug · Class 1 HRS9531注射液 · No verified English nameCXHS2500114 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/02New drug · Class 1 HRS9531注射液 · No verified English nameCXHS2500113 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/02New drug · Class 1 HRS9531注射液 · No verified English nameCXHS2500112 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized

124 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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