YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 31 August 2023 and 6 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 61 drug names.

2023/08/31 – 2023/09/06

Period
2023/08/31 to 2023/09/06, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
61
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

323filings, 85 of them generic

By application type

Application typeFilings
Supplement156
Generic85
New drug56
Import15
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug237
TCM55
Therapeutic biologic26
Prophylactic biologic4
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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection442
2Nicorandil for Injection321
3Etoricoxib Tablets318
4Quetiapine Fumarate Tablets310
5Tadalafil Tablets2223
6Nicorandil Tablets224
7Bumetanide Injection2213
8Potassium Chloride Injection2210
9Lornoxicam for Injection222
10Metaraminol Tartrate Injection222

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
2Haikou Shi Pharmaceutical Factory Co., Ltd. romanized620
3Haerbin Tong Yi Tang Pharma Co., Ltd. romanized550
4Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized530
5CISEN PHARMACEUTICAL CO., LTD.521
6Shenyang Hong Yao Group Co., Ltd. romanized430
7Guizhou Rui He Pharmaceutical Co., Ltd. romanized430
8Pfizer Europe MA EEIG420
9Rui Yang Pharmaceutical Co., Ltd. romanized420
10LianBio Development (SG) Pte. Ltd.410

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

100 this week

AcceptedDrugApplicants
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.
2023/09/05Import · Class 1 JDQ443片 · No verified English nameJXHL2300202 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2023/09/05Import · Class 1 DMX-200 · No verified English nameJXHL2300201 Dimerix Bioscience Pty Ltd; IQVIA RDS (Shanghai) Co. Ltd.
2023/09/05Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2302386 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2302385 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302378 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2302377 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2302376 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHL2300112 Health Yuan Pharma Group Co., Ltd. romanized
2023/09/05New drug · Class 1.1 藿夏感冒颗粒 · No verified English nameCXZL2300059 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized

70 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.