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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 397 drug applications between 18 April 2026 and 24 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 60 drug names.

2026/04/18 – 2026/04/24

Period
2026/04/18 to 2026/04/24, 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
397
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
110

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

397filings, 71 of them generic

By application type

Application typeFilings
Supplement227
Generic71
New drug68
Unspecified12
Import re-registration12
Import7

By drug type

Drug typeFilings
Chemical drug203
TCM137
Therapeutic biologic45
Biologic10
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿布昔替尼片 · No verified English name3112
2头孢丙烯干混悬剂 · No verified English name212
3Brexpiprazole Orally Disintegrating Tablets2110
4Sacubitril Valsartan Sodium Tablets2170
5盐酸氢吗啡酮片 · No verified English name210
6Esomeprazole Magnesium Enteric-Coated Capsules214
7Amlodipine Besylate Tablets218
8Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)215
9Dapagliflozin Tablets2184
10Ketoprofen Patches217

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

249 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S730
2Xinjiang Wei Wu Er Pharma Co., Ltd. romanized630
3Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized630
4AstraZeneca UK Limited620
5Ha Yao Group Bio Gong Cheng Co., Ltd. romanized620
6Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized550
7Fuzhou Min Hai Pharma Co., Ltd. romanized440
8Qilu Pharmaceutical Co., Ltd.440
9Bayer AG430
10Shandong Bo An Bio Technology Co., Ltd. romanized430

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

102 this week

AcceptedDrugApplicants
2026/04/24Import · Class 2.1 Tarlatamab(皮下注射) · No verified English nameJXSL2600102 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/04/24Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2600958 Anhui Sheng Ying Pharma Co., Ltd. romanized
2026/04/24Generic · Class 3 米诺地尔泡沫剂(男用) · No verified English nameCYHS2600956 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2026/04/24Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2600955 Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2026/04/24Generic · Class 3 Ferrous Succinate TabletsCYHS2600954 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2026/04/24Generic · Class 3 Sodium Nitroprusside InjectionCYHS2600947 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2026/04/24Generic · Class 3 Diprophylline InjectionCYHS2600944 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/04/24Generic · Class 3 Domiphen bromide Buccal TabletsCYHS2600940 Name not romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized
2026/04/24Generic · Class 3 盐酸奥昔布宁洗剂 · No verified English nameCYHL2600056 Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2026/04/24New drug · Class 1.2 筋骨草总环烯醚萜苷片 · No verified English nameCXZS2600021 Beijing Kang Chen Pharma Co., Ltd. romanized; Liaoning Wo Hua Kang Chen Pharmaceuticals Co., Ltd. romanized
2026/04/24New drug · Class 1.2 筋骨草总环烯醚萜苷 · No verified English nameCXZS2600020 Liaoning Wo Hua Kang Chen Pharmaceuticals Co., Ltd. romanized
2026/04/24New drug · Class 2.2 艾帕洛利托沃瑞利单抗注射液 · No verified English nameCXSS2600072 Qilu Pharmaceutical Co., Ltd.
2026/04/24New drug · Class 3.2 人血管性血友病因子 · No verified English nameCXSL2600442 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2026/04/24New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2600441 Shandong Bo An Bio Technology Co., Ltd. romanized
2026/04/24New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2600440 Shandong Bo An Bio Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 BA1106注射液 · No verified English nameCXSL2600439 Shandong Bo An Bio Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 BPR-30160639注射液 · No verified English nameCXHL2600503 Chengdu Bei Te Rui Ma Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 伊匹乌肽雾化吸入溶液 · No verified English nameCXHL2600499 Guangzhou Yi Ming Kang Bio Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 BIOS0629-109片 · No verified English nameCXHL2600498 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 BIOS0629-109片 · No verified English nameCXHL2600497 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 HS-20136-2注射液 · No verified English nameCXHL2600491 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 HS-20136-2注射液 · No verified English nameCXHL2600490 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 HS-20136-2注射液 · No verified English nameCXHL2600489 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/24New drug · Class 1 HS-20136-2注射液 · No verified English nameCXHL2600488 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/23Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSS2600040 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/23Import · Class 1 Denikitug · No verified English nameJXSL2600101 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/04/23Import · Class 1 Denikitug · No verified English nameJXSL2600100 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/04/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2600937 Hebei Long Hai Pharma Co., Ltd. romanized
2026/04/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2600936 Hebei Long Hai Pharma Co., Ltd. romanized
2026/04/23Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2600928 Jiangxi Yi You Pharma Co., Ltd. romanized

72 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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