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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 348 drug applications between 24 August 2023 and 30 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 58 drug names.

2023/08/24 – 2023/08/30

Period
2023/08/24 to 2023/08/30, 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
348
Drugs with new generic filings (by drug name, de-duplicated)
58
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

348filings, 74 of them generic

By application type

Application typeFilings
Supplement196
Generic74
New drug52
Import11
Import re-registration8
Unspecified7

By drug type

Drug typeFilings
Chemical drug235
TCM66
Therapeutic biologic40
Prophylactic biologic6
Biologic1

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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Rivaroxaban Tablets313
3Lidocaine and Prilocaine Cream2224
4Methotrexate Injection2211
5Oseltamivir Phosphate For Oral Suspension222
6Tacrolimus Ointment216
7Potassium Chloride Injection2110
8Pemetrexed Disodium for Injection214
9注射用头孢唑肟钠 · No verified English name214
10Nicorandil for Injection211

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized31270
2Guizhou Rui He Pharmaceutical Co., Ltd. romanized23230
3AstraZeneca AB730
4Celgene Corporation610
5GE Healthcare AS610
6Sanofi Winthrop Industrie610
7Sanofi-Aventis Deutschland GmbH550
8Novartis Europharm Limited520
9Qilu Pharmaceutical Co., Ltd.520
10Hainan Si Da Pharmaceutical Co., Ltd. romanized510

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

89 this week

AcceptedDrugApplicants
2023/08/30Import · Class 1 PF-06940434注射液 · No verified English nameJXSL2300159 Pfizer Inc.; Pfizer Investment CO. Ltd.
2023/08/30Generic · Class 3 盐酸丙卡特罗片 · No verified English nameCYHS2302320 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2023/08/30Generic · Class 3 Pentoxifylline InjectionCYHS2302319 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2302310 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/08/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302308 Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302307 Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Mesalamine extended release capsulesCYHS2302305 Beijing Foyou Pharma CO.,LTD
2023/08/30Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302304 Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
2023/08/30Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2302302 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2302299 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Nicorandil for InjectionCYHS2302298 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/08/30Generic · Class 3 Nicorandil for InjectionCYHS2302297 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/08/30Generic · Class 3 Calcium Gluconate InjectionCYHS2302296 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/30New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2300071 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2023/08/30New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2300587 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/08/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2300586 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/08/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2300585 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/08/30New drug · Class 1 注射用IMM2510 · No verified English nameCXSL2300584 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/30New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2300583 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/08/30New drug · Class 1 注射用JSKN003 · No verified English nameCXSL2300582 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2023/08/30New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300581 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/08/30New drug · Class 1 吡罗西尼片 · No verified English nameCXHS2300075 Xuan Zhu Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2023/08/30New drug · Class 2.2 盐酸氨溴索口服冻干片 · No verified English nameCXHL2300926 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2023/08/30New drug · Class 2.2 盐酸氨溴索口服冻干片 · No verified English nameCXHL2300925 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2023/08/29Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300072 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/08/29Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300071 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/08/29Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2302293 Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/08/29Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2302290 Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized
2023/08/29Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2302289 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 2.3 桑枝总生物碱片 · No verified English nameCXZL2300054 Beijing Wu He Bo Ao Pharma Co., Ltd. romanized

59 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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