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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 20 April 2026 and 26 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 62 drug names.

2026/04/20 – 2026/04/26

Period
2026/04/20 to 2026/04/26, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
119

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

404filings, 72 of them generic

By application type

Application typeFilings
Supplement230
New drug73
Generic72
Unspecified12
Import re-registration9
Import8

By drug type

Drug typeFilings
Chemical drug209
TCM129
Therapeutic biologic51
Biologic10
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

62 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
2Brexpiprazole Orally Disintegrating Tablets2110
3Sacubitril Valsartan Sodium Tablets2170
4盐酸氢吗啡酮片 · No verified English name210
5Esomeprazole Magnesium Enteric-Coated Capsules214
6Amlodipine Besylate Tablets218
7Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)215
8Dapagliflozin Tablets2184
9Ketoprofen Patches217
10Omega-3-acid ethyl ester 90 Soft Capsules1111

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

251 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S730
2Ha Yao Group Pharmaceutical Factory romanized720
3Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized630
4AstraZeneca UK Limited620
5Ha Yao Group Bio Gong Cheng Co., Ltd. romanized620
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized550
8Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized540
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD440
10Qilu Pharmaceutical Co., Ltd.440

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

105 this week

AcceptedDrugApplicants
2026/04/25Import · Class 1 LY4298445注射液 · No verified English nameJXSL2600103 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/04/25Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2600966 Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2026/04/25New drug · Class 3.1 芍药甘草汤颗粒 · No verified English nameCXZS2600022 Anhui Xie He Cheng Pharmaceutical Co., Ltd. romanized
2026/04/25New drug · Class 1 注射用MST-168单抗 · No verified English nameCXSL2600444 Mu Bao Sheng Ke Biopharmaceuticals (Guangdong Heng Qin) Co., Ltd. romanized
2026/04/25New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2600443 Sichuan Ming Rui Jia Bio Technology Co., Ltd. romanized
2026/04/25New drug · Class 2.2 HL231吸入溶液 · No verified English nameCXHS2600060 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2026/04/25New drug · Class 1 BW-50920注射液 · No verified English nameCXHL2600504 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2026/04/25New drug · Class 1 DZ-002注射液 · No verified English nameCXHL2600502 Shenzhen Shi Wei Hang Yi Ning Bio Technology Co., Ltd. romanized
2026/04/25New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2600501 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/04/25New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2600500 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
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

75 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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