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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 495 drug applications between 31 January 2026 and 6 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 63 drug names.

2026/01/31 – 2026/02/06

Period
2026/01/31 to 2026/02/06, 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
495
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
138

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

495filings, 92 of them generic

By application type

Application typeFilings
Supplement297
Generic92
New drug63
Import re-registration17
Unspecified16
Import10

By drug type

Drug typeFilings
Chemical drug255
TCM181
Therapeutic biologic51
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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets515
2Cyclophosphamide Injection316
3Edoxaban Tosilate Tablets319
4莫立司他钠片 · No verified English name310
5Ibuprofen Suspension2214
6氧 · No verified English name2215
7Dapagliflozin Tablets2284
8Fluticasone Propionate Cream2112
9Diclofenac Diethylamine Emulgel2120
10Cefditoren Pivoxil Granules2118

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized60460
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized45230
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized21200
4Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized1080
5Bayer AG620
6Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
8Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized550
9Jiangxi Wang Shi Pharma Co., Ltd. romanized550
10Ai Min Pharma Group Co., Ltd. romanized550

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

108 this week

AcceptedDrugApplicants
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
2026/02/06New drug · Class 2.4; 2.2 BH015注射液 · No verified English nameCXHL2600154 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2026/02/06New drug · Class 1 注射用JKN2502 · No verified English nameCXHL2600153 Health Yuan Pharma Group Co., Ltd. romanized
2026/02/06New drug · Class 2.1; 2.2; 2.4 H009L注射液 · No verified English nameCXHL2600152 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2026/02/05Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600381 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 盐酸溴己新吸入溶液 · No verified English nameCYHS2600380 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 盐酸溴己新吸入溶液 · No verified English nameCYHS2600379 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600376 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600375 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600374 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Ferrous Succinate TabletsCYHS2600370 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized
2026/02/05New drug · Class 1.1 双鱼颗粒 · No verified English nameCXZS2600012 Jiangsu Kang Yuan Pharma Co., Ltd. romanized

78 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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