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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 514 drug applications between 1 February 2026 and 7 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 55 drug names.

2026/02/01 – 2026/02/07

Period
2026/02/01 to 2026/02/07, 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
514
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
126

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

514filings, 79 of them generic

By application type

Application typeFilings
Supplement336
Generic79
New drug62
Import re-registration16
Unspecified12
Import9

By drug type

Drug typeFilings
Chemical drug235
TCM221
Therapeutic biologic50
Biologic7
Prophylactic 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

55 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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized123950
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized34170
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized21200
4Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized1080
5AstraZeneca AB740
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
7Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized550
8Ai Min Pharma Group Co., Ltd. romanized550
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
10Bayer AG510

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

99 this week

AcceptedDrugApplicants
2026/02/07Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600035 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/02/07Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600034 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/02/07Import · Class 2.4 依普隆特生钠注射液 · No verified English nameJXHL2600033 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/02/07Generic · Class 3 Ferrous Succinate TabletsCYHS2600404 Beijing Ren Zhong Pharma Co., Ltd. romanized
2026/02/07Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2600403 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized
2026/02/07New drug · Class 2.3 西帕依麦孜彼子口服液 · No verified English nameCXZL2600022 Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized; Qi Mu (Guangdong Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized
2026/02/07New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2600016 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized
2026/02/07New drug · Class 1 ALXN2220注射液 · No verified English nameCXSL2600185 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2026/02/07New drug · Class 1 ZHB117舌下片 · No verified English nameCXSL2600184 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/02/07New drug · Class 1 ZHB117舌下片 · No verified English nameCXSL2600183 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/02/07New drug · Class 1 注射用GLR1059 · No verified English nameCXSL2600182 Gan Li Pharma Co., Ltd. romanized
2026/02/06Import · Class 1 伊利尤单抗注射液 · No verified English nameJXSS2600007 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2026/02/06Import · Class 1 伊利尤单抗注射液 · No verified English nameJXSS2600006 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2026/02/06Import · Class 2.4 宗艾替尼片 · No verified English nameJXHL2600032 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/02/06Generic · Class 3 Amikacin Sulfate injectionCYHS2600409 Shandong An Xin Pharmaceutical Co., Ltd. romanized; Qilu Pharmaceutical Co., Ltd.
2026/02/06Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2600398 Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2026/02/06Generic · Class 3 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2600396 Hua Ren Pharma Co., Ltd. romanized
2026/02/06Generic · Class 3 利格列汀二甲双胍缓释片(Ⅱ) · No verified English nameCYHS2600392 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2026/02/06Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2600388 Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2026/02/06Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2600387 Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2026/02/06Generic · Class 3 Amisulpride Oral SolutionCYHS2600386 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2026/02/06Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2600385 Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2026/02/06Generic · Class 3 Cabozantinib TabletsCYHL2600021 Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized
2026/02/06New drug · Class 3.1 达原饮颗粒 · No verified English nameCXZS2600013 Shandong Qidu Pharmaceutical Co., Ltd.
2026/02/06New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2600015 Beijing SL Pharmaceutical Co., Ltd.
2026/02/06New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2600181 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2026/02/06New drug · Class 3.3 度普利尤单抗注射液 · No verified English nameCXSL2600180 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized
2026/02/06New drug · Class 2.2 重组人神经生长因子滴眼液 · No verified English nameCXSL2600179 Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized
2026/02/06New drug · Class 2.2 重组人神经生长因子滴眼液 · No verified English nameCXSL2600178 Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized
2026/02/06New drug · Class 1 甲磺酸艾多替尼片 · No verified English nameCXHS2600026 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized

69 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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