YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 285 drug applications between 24 January 2024 and 30 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 69 drug names.

2024/01/24 – 2024/01/30

Period
2024/01/24 to 2024/01/30, 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
285
Drugs with new generic filings (by drug name, de-duplicated)
69
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

285filings, 95 of them generic

By application type

Application typeFilings
Supplement109
Generic95
New drug44
Import re-registration21
Import12
Unspecified3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug208
TCM40
Therapeutic biologic28
Prophylactic biologic6
Biologic3

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops325
2Riociguat Tablets314
3Levofloxacin Eye Drops2216
4Bisoprolol Fumarate and Amlodipine Besylate Tablets229
5氧(液态) · No verified English name2213
6Famotidine Injection228
7Penehyclidine Hydrochloride Injection222
8Roxadustat Capsules2217
9Nintedanib Esilate Soft Capsules216
10Lactulose Oral Solution2134

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized858
2Hubei Fu Ren Jin Shen Pharma Co., Ltd. romanized770
3Sanofi -aventis France710
4AstraZeneca AB420
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD422
6Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
7Novo Nordisk A/S330
8BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED320
9Merck Sharp & Dohme LLC320
10Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized321

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

87 this week

AcceptedDrugApplicants
2024/01/30Import · Class 1 GSK1070806注射液 · No verified English nameJXSL2400028 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD
2024/01/30Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2400398 Shenzhen Hua Yao Nan Fang Pharmaceutical Co., Ltd. romanized
2024/01/30Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2400385 Xizang Bang Chen Pharma Group Co., Ltd. romanized; Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2024/01/30New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2400069 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/01/30New drug · Class 1 靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液 · No verified English nameCXSL2400068 Wuhan Bo Rui Da Bio Technology Co., Ltd. romanized
2024/01/30New drug · Class 1 HSK16149胶囊 · No verified English nameCXHL2400122 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2024/01/30New drug · Class 2.3 度他雄胺坦索罗辛胶囊 · No verified English nameCXHL2400121 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2024/01/30New drug · Class 2.2; 2.4 乙醇注射液(含碘普罗胺) · No verified English nameCXHL2400120 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/01/29Generic · Class 3 Peramivir InjectionCYHS2400380 Henan Run Hong Pharmaceutical Co., Ltd. romanized
2024/01/29New drug · Class 1.1 喉喑清胶囊 · No verified English nameCXZS2400007 Guizhou Rui He Pharmaceutical Co., Ltd. romanized
2024/01/28New drug · Class 1 FHND6091胶囊 · No verified English nameCXHL2400119 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/01/28New drug · Class 1 FHND6091胶囊 · No verified English nameCXHL2400118 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/01/27Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400373 Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2024/01/27Generic · Class 3 Atropine Sulfate InjectionCYHS2400371 Henan Pu Rui Pharma Co., Ltd. romanized
2024/01/27Generic · Class 3 Potassium Chloride GranulesCYHS2400365 Guangzhou Sen Rong Pharmaceuticals Technology Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized
2024/01/27Generic · Class 3 Potassium Chloride GranulesCYHS2400364 Guangzhou Sen Rong Pharmaceuticals Technology Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized
2024/01/27Generic · Class 3 Aminocaproic Acid InjectionCYHS2400362 Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized
2024/01/27New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2400015 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/01/26Import · Class 2.2 埃万妥单抗注射液 · No verified English nameJXSS2400004 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.
2024/01/26Import · Class 2.4 甲磺酸兰泽替尼片 · No verified English nameJXHS2400009 Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd.
2024/01/26Generic · Class 3 Hydromorphone Hydrochloride InjectionCYHS2400358 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2024/01/26Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2400355 Nanjing Ming Sheng Pharmaceuticals Co., Ltd. romanized; Nanjing Bai Jing Yu Pharmaceutical Co., Ltd. romanized
2024/01/26Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2400354 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2024/01/26Generic · Class 3 特利加压素注射液 · No verified English nameCYHS2400353 CISEN PHARMACEUTICAL CO., LTD.
2024/01/26New drug · Class 1.1 牛黄小儿退热贴 · No verified English nameCXZS2400006 Jian Min Pharma Group Co., Ltd. romanized
2024/01/26New drug · Class 1 IBR822细胞注射液 · No verified English nameCXSL2400067 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2024/01/26New drug · Class 3.3 ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载体) · No verified English nameCXSL2400066 Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2024/01/26New drug · Class 1 TQC3927吸入粉雾剂 · No verified English nameCXHL2400117 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/26New drug · Class 1 TQC3927吸入粉雾剂 · No verified English nameCXHL2400116 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400115 Hua Run Shuang He Pharma Co., Ltd. romanized

57 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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