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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 20 December 2023 and 26 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 72 drug names.

2023/12/20 – 2023/12/26

Period
2023/12/20 to 2023/12/26, 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
360
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

360filings, 100 of them generic

By application type

Application typeFilings
Supplement163
Generic100
New drug53
Import24
Unspecified12
Import re-registration8

By drug type

Drug typeFilings
Chemical drug249
TCM62
Therapeutic biologic42
Biologic3
Prophylactic biologic3
In vitro diagnostic reagent1

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
1Lactulose Oral Solution4334
2Carboplatin Injection4210
3Vonoprazan Fumarate Tablets4260
4Roxadustat Capsules3217
5Ketorolac Tromethamine Injection324
6Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
7Ceftazidime And Avibactam Sodium For Injection2212
8Progesterone Sustained-release Vaginal Gel222
9Folic acid injection211
10Diquafosol Sodium Eye Drops215

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized1410
2AstraZeneca AB950
3Shenyang Hong Yao Group Co., Ltd. romanized760
4Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized630
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
6Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized550
7Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized530
8Hainan Xu Wo Pharma Co., Ltd. romanized440
9Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized434
10Jiangsu Lianhuan Pharmaceutical Co.,Ltd.432

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

106 this week

AcceptedDrugApplicants
2023/12/26Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2300235 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/26Import · Class 1 BI1569912 片 · No verified English nameJXHL2300328 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/12/26Import · Class 1 BI1569912 片 · No verified English nameJXHL2300327 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/12/26Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2303623 Shandong Ke Lun Pharma Co., Ltd. romanized
2023/12/26Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2303622 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized
2023/12/26Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2303617 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2023/12/26Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2303616 Jiangsu Ming Sheng Kang Yuan Pharma Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/12/26Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHS2303613 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/12/26Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHS2303612 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/12/26Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2303608 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2023/12/26Generic · Class 3 Acetylcysteine InjectionCYHS2303606 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/12/26Generic · Class 3 Sodium Bicarbonate InjectionCYHS2303605 Guangdong Ding Xin Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/12/26Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303601 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2023/12/26Generic · Class 3 盐酸氨酮戊酸口服溶液用粉末 · No verified English nameCYHL2300157 Tai Zhou Fu Dan Zhang Jiang Pharma Co., Ltd. romanized
2023/12/26New drug · Class 1.1 铁皮石斛咀嚼片 · No verified English nameCXZL2300075 Hangzhou Dan He Pharmaceuticals Co., Ltd. romanized
2023/12/26New drug · Class 1 KH801注射液 · No verified English nameCXSL2300890 Beijing Kang Hong Biopharmaceuticals Co., Ltd. romanized
2023/12/26New drug · Class 1 HLX6018 · No verified English nameCXSL2300889 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/12/26New drug · Class 1 注射用MK-1200 · No verified English nameCXSL2300888 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/12/26New drug · Class 1 VIC-1911片 · No verified English nameCXHL2301448 Jie Si Ying Da Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Jie Si Ying Da Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2023/12/26New drug · Class 1 FHND6091胶囊 · No verified English nameCXHL2301447 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2023/12/26New drug · Class 1 FHND6091胶囊 · No verified English nameCXHL2301446 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2023/12/26New drug · Class 1 GY-1068胶囊 · No verified English nameCXHL2301445 Shanghai Gui Zhi Yan Pharmaceuticals Technology Co., Ltd. romanized
2023/12/26New drug · Class 1 LD09163片 · No verified English nameCXHL2301444 Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized
2023/12/26New drug · Class 1 LD09163片 · No verified English nameCXHL2301443 Shanghai Li Dao Pharmaceuticals Technology Co., Ltd. romanized
2023/12/26New drug · Class 1 注射用AST2169脂质体 · No verified English nameCXHL2301442 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2023/12/25Import · Class 1 AZD9829 · No verified English nameJXSL2300234 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd
2023/12/25Import · Class 1 Etavopivat · No verified English nameJXHL2300326 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/12/25Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2303595 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/12/25Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2303594 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/25Generic · Class 3 Folic acid injectionCYHS2303593 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized

76 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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