YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 298 drug applications between 20 January 2024 and 26 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 72 drug names.

2024/01/20 – 2024/01/26

Period
2024/01/20 to 2024/01/26, 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
298
Drugs with new generic filings (by drug name, de-duplicated)
72
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

298filings, 92 of them generic

By application type

Application typeFilings
Supplement105
Generic92
New drug62
Import18
Import re-registration17
Unspecified3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug211
Therapeutic biologic41
TCM38
Prophylactic biologic7
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

72 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Calcium Folinate Injection314
2Diprophylline Injection227
3Levofloxacin Eye Drops2216
4氧(液态) · No verified English name2213
5Famotidine Injection228
6Roxadustat Capsules2217
7Lactulose Oral Solution2134
8Tadalafil Tablets2123
9Betamethasone Sodium Phosphate Injection215
10Risperidone Orally Disintegrating Tablets210

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin He Zang Yao Co., Ltd. romanized770
2Sanofi -aventis France710
3Amgen Inc.620
4Jilin Wu Tai Gan Kang Pharma Co., Ltd. romanized550
5Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized430
6AstraZeneca AB420
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD422
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
9Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
10Boehringer Ingelheim International GmbH330

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

120 this week

AcceptedDrugApplicants
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
2024/01/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400114 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/01/26New drug · Class 1 HJ-002-03片 · No verified English nameCXHL2400113 He Jing Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/01/26New drug · Class 1 HJ-002-03片 · No verified English nameCXHL2400112 He Jing Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/01/25Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2400003 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2024/01/25Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2400002 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2024/01/25Generic · Class 3 Potassium Phosphates InjectionCYHS2400350 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Memantine Hydrochloride OD TabletsCYHS2400349 Hefei En Rui Te Pharma Co., Ltd. romanized
2024/01/25Generic · Class 3 Avanafil TabletsCYHS2400348 Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400345 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400344 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Famotidine InjectionCYHS2400342 Name not romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2024/01/25Generic · Class 3 Doxercalciferol InjectionCYHS2400341 Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Potassium Aspartate InjectionCYHS2400339 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/01/25Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2400336 Shandong Qidu Pharmaceutical Co., Ltd.; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/25Generic · Class 3 Delafloxacin for InjectionCYHL2400025 Shandong Qidu Pharmaceutical Co., Ltd.
2024/01/25Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHL2400024 Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized
2024/01/25New drug · Class 1 注射用DB-1310 · No verified English nameCXSL2400065 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/01/25New drug · Class 1 JMT106注射液 · No verified English nameCXSL2400064 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized

90 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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