YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 11 July 2025 and 17 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 82 drug names.

2025/07/11 – 2025/07/17

Period
2025/07/11 to 2025/07/17, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
77

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

389filings, 118 of them generic

By application type

Application typeFilings
Supplement150
Generic118
New drug84
Import22
Import re-registration12
Unspecified3

By drug type

Drug typeFilings
Chemical drug267
TCM67
Therapeutic biologic48
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Minoxidil Liniment4252
3Guanfacine Hydrochloride Extended Release Tablets414
4Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
5Acetylcysteine Injection2253
6双氯芬酸钠盐酸利多卡因注射液 · No verified English name228
7噻托溴铵吸入喷雾剂 · No verified English name221
8Baricitinib Tablets2232
9瑞维那新吸入溶液 · No verified English name2253
10Nicardipine Hydrochloride Injection2213

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

245 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized12612
2Jiangxi Qing Feng Pharma Co., Ltd. romanized880
3Bracco Imaging S.P.A.610
4AstraZeneca AB520
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
6Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.432
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
9Hunan Jiudian Pharmaceutical Co., Ltd420
10F. Hoffmann-La Roche Ltd410

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

154 this week

AcceptedDrugApplicants
2025/07/17Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2500101 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/07/17Import · Class 3.1 加达西单抗注射液 · No verified English nameJXSS2500100 CSL Behring AG; CSL Behring GmbH; PAREXEL CHINA CO. LTD
2025/07/17Import · Class 2.2 罗培干扰素α-2b注射液 · No verified English nameJXSS2500099 PharmaEssentia Corporation; PharmaEssentia Corporation Taichung Plant; PharmaEssentia Biotechnology (Beijing) Company limited
2025/07/17Import · Class 1 Leflutrozole胶囊 · No verified English nameJXHL2500186 ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd.
2025/07/17Import · Class 1 Leflutrozole胶囊 · No verified English nameJXHL2500185 ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd.
2025/07/17Import · Class 1 Leflutrozole胶囊 · No verified English nameJXHL2500184 ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd.
2025/07/17Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2502573 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/07/17Generic · Class 3 Sucralfate Oral SuspensionCYHS2502571 Qingdao Shuang Jing Pharma Co., Ltd. romanized
2025/07/17Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2502568 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized
2025/07/17Generic · Class 3 Bifonazole SolutionCYHS2502567 Jiangsu He Chen Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.
2025/07/17Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500129 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/17Generic · Class 3 卡左双多巴肠凝胶 · No verified English nameCYHL2500128 Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2025/07/17New drug · Class 1 注射用YLSH003 · No verified English nameCXSL2500600 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2025/07/17New drug · Class 1 EMB-07注射液 · No verified English nameCXSL2500599 Shanghai An Mai Bio Technology Co., Ltd. romanized
2025/07/17New drug · Class 2.2 SQ-129玻璃体缓释注射液 · No verified English nameCXHL2500712 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/07/17New drug · Class 2.2 SQ-129玻璃体缓释注射液 · No verified English nameCXHL2500711 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/07/17New drug · Class 1 SYH2070注射液 · No verified English nameCXHL2500709 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/07/17New drug · Class 2.2 LPD-003原位凝胶 · No verified English nameCXHL2500708 Zhejiang Zi Teng Pharma Technology Co., Ltd. romanized
2025/07/17New drug · Class 1 GTA182片 · No verified English nameCXHL2500707 Shanghai Pai Long Bio Technology Co., Ltd. romanized
2025/07/17New drug · Class 1 GTA182片 · No verified English nameCXHL2500706 Shanghai Pai Long Bio Technology Co., Ltd. romanized
2025/07/17New drug · Class 1 D-2570片 · No verified English nameCXHL2500705 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2025/07/17New drug · Class 1 PH027-1片 · No verified English nameCXHL2500704 Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized
2025/07/17New drug · Class 1 PH027-1片 · No verified English nameCXHL2500703 Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized
2025/07/16Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500103 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/16Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500102 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502556 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502555 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2502554 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/07/16Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2502553 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized
2025/07/16Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2502552 Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized

124 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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