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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 28 August 2024 and 3 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 78 drug names.

2024/08/28 – 2024/09/03

Period
2024/08/28 to 2024/09/03, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
78
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

329filings, 102 of them generic

By application type

Application typeFilings
Supplement148
Generic102
New drug63
Import9
Unspecified5
Import re-registration2

By drug type

Drug typeFilings
Chemical drug226
TCM58
Therapeutic biologic37
Prophylactic biologic8

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection4213
2Rivaroxaban Tablets413
3维生素B6注射液 · No verified English name3310
4Tadalafil Tablets3123
5Gadobutrol Injection318
6Lactated Ringer's Injection215
7依伏卡塞片 · No verified English name219
8Empagliflozin Tablets2118
9Sildenafil Citrate Tablets2112
10Nafamostat Mesilate for Injection2138

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized650
2Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized530
3Jiangsu Kang Yuan Pharma Co., Ltd. romanized520
4Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized444
5Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized440
6Guizhou Liang Ji Pharma Co., Ltd. romanized440
7Qingdao Dong Hai Pharma Co., Ltd. romanized440
8Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized424
9Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized414
10Jiangsu En Hua Pharma Co., Ltd. romanized410

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
2024/09/03Import · Class 1 AMG 193 · No verified English nameJXHL2400211 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/09/03Generic · Class 3 Famotidine InjectionCYHS2402887 Suzhou Hong Sen Pharma Co., Ltd. romanized
2024/09/03Generic · Class 3 Bilastine Orally disintegrating TabletsCYHS2402884 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/09/03Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402879 Shanxi Kang Cheng Li An Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/09/03New drug · Class 1 注射用艾帕依泊汀α · No verified English nameCXSS2400094 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2024/09/03New drug · Class 1 注射用艾帕依泊汀α · No verified English nameCXSS2400093 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2024/09/03New drug · Class 1 SM3321注射液 · No verified English nameCXSL2400586 Beijing Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/03New drug · Class 1 9MW2821 · No verified English nameCXSL2400585 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2024/09/03New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2400584 Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2024/09/03New drug · Class 1 NH160030片 · No verified English nameCXHL2400899 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2024/09/03New drug · Class 1 NH160030片 · No verified English nameCXHL2400898 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2024/09/03New drug · Class 1 NH160030片 · No verified English nameCXHL2400897 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2024/09/03New drug · Class 1 NH160030片 · No verified English nameCXHL2400896 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized
2024/09/02New drug · Class 3.1 二冬颗粒 · No verified English nameCXZS2400029 Shen Wei Pharma Group Co., Ltd. romanized
2024/09/02New drug · Class 1 ALMB-0168注射液 · No verified English nameCXSL2400582 Shanghai En Le Mai Bio Technology Co., Ltd. romanized
2024/09/02New drug · Class 1 人生长激素-Fc融合蛋白注射液 · No verified English nameCXSL2400581 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/09/02New drug · Class 2.2 尼莫地平注射用浓溶液 · No verified English nameCXHL2400895 Beijing De Li Fu Rui Pharmaceuticals Technology Co., Ltd. romanized
2024/09/02New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2400894 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402869 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402868 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402867 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/09/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402866 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/08/31Import · Class 2.4 Sulfur Hexafluoride Microbubbles for InjectionJXHS2400060 Bracco International B.V.; Bracco Suisse SA; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2024/08/31Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402865 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/08/31Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402860 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/31Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2402858 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/08/31Generic · Class 3 Revefenacin inhalation solutionCYHL2400182 Zhang Feng Pharma Co., Ltd. romanized
2024/08/31New drug · Class 1.1 玉蚕颗粒 · No verified English nameCXZL2400049 Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized; Shanghai Fu Huo Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/08/31New drug · Class 1.1 膝痛颗粒 · No verified English nameCXZL2400048 Zhong Yi (Guangzhou) Technology Innovation Research Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized
2024/08/31New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2400092 Cheng Da Bio (Ben Xi) 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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