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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 385 drug applications between 21 August 2023 and 27 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 63 drug names.

2023/08/21 – 2023/08/27

Period
2023/08/21 to 2023/08/27, 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
385
Drugs with new generic filings (by drug name, de-duplicated)
63
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

385filings, 84 of them generic

By application type

Application typeFilings
Supplement212
Generic84
New drug47
Unspecified17
Import16
Import re-registration9

By drug type

Drug typeFilings
Chemical drug262
TCM82
Therapeutic biologic33
Biologic6
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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Injection5410
2Rivaroxaban Tablets313
3Tadalafil Tablets2223
4Bisoprolol Fumarate and Amlodipine Besylate Tablets229
5Famotidine Injection228
6Lornoxicam for Injection222
7Bortezomib For Injection221
8Oseltamivir Phosphate For Oral Suspension222
9复方奥美拉唑干混悬剂 · No verified English name210
10Montelukast Sodium Chewable Tablets214

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

221 companies with new acceptances; top 10 listed

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

110 this week

AcceptedDrugApplicants
2023/08/26Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302279 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2302276 Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2023/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2302275 Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2023/08/26Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302274 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 SCG101自体T细胞注射液 · No verified English nameCXSL2300577 Xing Han De Biopharmaceuticals (Da Lian) Co., Ltd. romanized
2023/08/26New drug · Class 3.3 重组抗CTLA-4全人单克隆抗体注射液 · No verified English nameCXSL2300576 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/08/26New drug · Class 1 IMP4297胶囊 · No verified English nameCXHS2300074 Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 IMP4297胶囊 · No verified English nameCXHS2300073 Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 SZJK-0421片 · No verified English nameCXHL2300917 Shenzhen Ji Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/08/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2300916 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/08/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2300915 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/08/25Import · Class 1 AZD5335 · No verified English nameJXSL2300158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/08/25Import · Class 1 AZD5305 · No verified English nameJXHL2300200 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/08/25Import · Class 1 AZD5305 · No verified English nameJXHL2300199 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/08/25Import · Class 1 AZD5305 · No verified English nameJXHL2300198 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/08/25Import · Class 1 AZD5305 · No verified English nameJXHL2300197 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/08/25Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2302273 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/08/25Generic · Class 3 Acetylcysteine InjectionCYHS2302272 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/08/25Generic · Class 3 脑脊髓手术用灌流液 · No verified English nameCYHS2302269 Shandong Qidu Pharmaceutical Co., Ltd.
2023/08/25Generic · Class 3 Minoxidil Topical SolutionCYHS2302268 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/08/25Generic · Class 3 Minoxidil Topical SolutionCYHS2302267 Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/08/25Generic · Class 3 Florbetapir F-18 InjectionCYHS2302261 Beijing Xin He Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized
2023/08/25Generic · Class 3 Levocarnitine TabletsCYHL2300107 Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized
2023/08/25Generic · Class 3 注射用乳糖酸克拉霉素 · No verified English nameCYHL2300106 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2023/08/25New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2300575 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2023/08/25New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2300574 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2023/08/25New drug · Class 1 EB070注射液 · No verified English nameCXSL2300573 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized
2023/08/25New drug · Class 1 CRTE7A2-01 TCR-T细胞注射液 · No verified English nameCXSL2300572 Beijing Ke Rui Bio Technology Co., Ltd. romanized
2023/08/25New drug · Class 3.4 QL2111注射液 · No verified English nameCXSL2300571 Qilu Pharmaceutical Co., Ltd.
2023/08/25New drug · Class 1 GH21胶囊 · No verified English nameCXHL2300914 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized

80 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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