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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 326 drug applications between 1 September 2023 and 7 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.

2023/09/01 – 2023/09/07

Period
2023/09/01 to 2023/09/07, 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
326
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
0

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

326filings, 76 of them generic

By application type

Application typeFilings
Supplement174
Generic76
New drug54
Import13
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug237
TCM54
Therapeutic biologic29
Prophylactic biologic5
In vitro diagnostic reagent1

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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection442
2Etoricoxib Tablets318
3Quetiapine Fumarate Tablets310
4Nicorandil Tablets224
5Bumetanide Injection2213
6Potassium Chloride Injection2210
7Lornoxicam for Injection222
8Metaraminol Tartrate Injection222
9Indobufen Tablets216
10Vortioxetine Hydrobromide Tablets2110

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haerbin Tong Yi Tang Pharma Co., Ltd. romanized11110
2Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
3Haikou Shi Pharmaceutical Factory Co., Ltd. romanized620
4Shenyang Hong Yao Group Co., Ltd. romanized540
5Pfizer Europe MA EEIG530
6Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized530
7CISEN PHARMACEUTICAL CO., LTD.521
8AstraZeneca AB430
9Guizhou Rui He Pharmaceutical Co., Ltd. romanized430
10MSD Merck Sharp & Dohme AG420

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
2023/09/07Import · Class 1 AGN-151586 · No verified English nameJXSL2300164 AbbVie Inc.; Allergan Information Consulting (Shanghai) Co. Ltd
2023/09/07Generic · Class 3 Diprophylline InjectionCYHS2302403 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/09/07New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSS2300074 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/09/07New drug · Class 1 注射用ZHB114 · No verified English nameCXSL2300601 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized; Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/09/07New drug · Class 2.4 林普利塞片 · No verified English nameCXHS2300076 Shanghai Ying Li Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2023/09/07New drug · Class 1 SPH7854颗粒 · No verified English nameCXHL2300966 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/09/07New drug · Class 1 SPH7854颗粒 · No verified English nameCXHL2300965 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/09/07New drug · Class 1 SPH7854颗粒 · No verified English nameCXHL2300964 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/09/07New drug · Class 2.3 右美沙芬去氧肾上腺素口服溶液 · No verified English nameCXHL2300963 Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/09/06Import · Class 1 AMG 133 · No verified English nameJXSL2300163 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2023/09/06Generic · Class 3 Bumetanide InjectionCYHS2302402 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2302400 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 Nicorandil for InjectionCYHS2302399 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 Nicorandil for InjectionCYHS2302398 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 Levocarnitine TabletsCYHS2302397 Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized
2023/09/06Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302395 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 Mercaptopurine TabletsCYHS2302394 Zhejiang Cheng Yi Pharma Co., Ltd. romanized
2023/09/06Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2302389 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/09/06Generic · Class 3 Trelagliptin Succinate TabletsCYHL2300114 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/09/06New drug · Class 3.3 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) · No verified English nameCXSS2300073 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/09/06New drug · Class 2.2 BCM857口溶膜 · No verified English nameCXHL2300962 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2023/09/06New drug · Class 2.2 BCM857口溶膜 · No verified English nameCXHL2300961 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2023/09/06New drug · Class 1 NH103草酸盐片 · No verified English nameCXHL2300960 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/09/06New drug · Class 1 NH103草酸盐片 · No verified English nameCXHL2300959 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/09/06New drug · Class 1 NH103草酸盐片 · No verified English nameCXHL2300958 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/09/06New drug · Class 1 NH103草酸盐片 · No verified English nameCXHL2300957 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/09/06New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2300956 Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized
2023/09/06New drug · Class 1 TM471-1胶囊 · No verified English nameCXHL2300955 Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized
2023/09/05Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300076 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd.
2023/09/05Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300075 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd.

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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