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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 454 drug applications between 7 February 2025 and 13 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 163, covering 109 drug names.

2025/02/07 – 2025/02/13

Period
2025/02/07 to 2025/02/13, 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
454
Drugs with new generic filings (by drug name, de-duplicated)
109
Accepted this week, now under review
21

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

454filings, 163 of them generic

By application type

Application typeFilings
Generic163
Supplement143
New drug103
Import28
Import re-registration11
Unspecified6

By drug type

Drug typeFilings
Chemical drug321
Therapeutic biologic86
TCM41
Prophylactic biologic4
Biologic2

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

109 drugs with new generic filings; top 10 listed

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

276 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized1030
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized820
3CSPC OUYI PHARMACEUTICAL CO., LTD.643
4Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized550
5Novartis Pharma AG530
6Sichuan Kelun Pharmaceutical Co., Ltd.532
7Jiangsu Kang Yuan Pharma Co., Ltd. romanized535
8Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized535
9Novo Nordisk A/S510
10Beijing Hua Shen Pharmaceutical Co., Ltd. romanized440

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

191 this week

AcceptedDrugApplicants
2025/02/13Import · Class 3.1 西妥昔单抗注射液 · No verified English nameJXSS2500012 Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd.
2025/02/13Import · Class 2.2 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2500025 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2025/02/13Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2500734 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Ferrous Succinate TabletsCYHS2500733 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2500732 Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2500731 Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Diprophylline InjectionCYHS2500730 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2500729 Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Potassium Phosphates InjectionCYHS2500728 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/02/13Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2500725 Shandong Yi Kang Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2500724 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500723 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2500722 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2500720 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Nitroglycerin InjectionCYHS2500719 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/02/13Generic · Class 3 Nitroglycerin InjectionCYHS2500718 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/02/13Generic · Class 3 Bilastine Orally disintegrating TabletsCYHS2500717 Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Bifonazole SolutionCYHS2500716 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/02/13Generic · Class 3 Topiroxostat TabletsCYHL2500040 Changchun Hai Yue Pharma Co., Ltd. romanized
2025/02/13Generic · Class 3 Topiroxostat TabletsCYHL2500039 Changchun Hai Yue Pharma Co., Ltd. romanized
2025/02/13New drug · Class 3.1 真武颗粒 · No verified English nameCXZS2500007 Kang Pu Pharma Co., Ltd. romanized
2025/02/13New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2500006 Hubei Ji An Tang Pharma Co., Ltd. romanized
2025/02/13New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500144 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/13New drug · Class 1 注射用ESG406 · No verified English nameCXSL2500143 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2025/02/13New drug · Class 1 注射用XTL6001 · No verified English nameCXSL2500142 Shanghai Xi Tai Li Biopharmaceuticals Technology Co., Ltd. romanized
2025/02/13New drug · Class 1 IAH0968 · No verified English nameCXSL2500141 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2025/02/13New drug · Class 1 注射用BAT7111 · No verified English nameCXSL2500140 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/02/13New drug · Class 1 HEC-007注射液 · No verified English nameCXHL2500199 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2025/02/13New drug · Class 1 HEC-007注射液 · No verified English nameCXHL2500198 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2025/02/13New drug · Class 1 HEC-007注射液 · No verified English nameCXHL2500197 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized

161 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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