YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 383 drug applications between 13 July 2023 and 19 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 47 drug names.

2023/07/13 – 2023/07/19

Period
2023/07/13 to 2023/07/19, 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
383
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
0

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

383filings, 67 of them generic

By application type

Application typeFilings
Supplement191
Generic67
New drug61
Import31
Import re-registration23
Unspecified10

By drug type

Drug typeFilings
Chemical drug278
Therapeutic biologic52
TCM47
Prophylactic biologic5
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

47 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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32230
2AstraZeneca AB1340
3Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized11100
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
5Boehringer Ingelheim International GmbH640
6Chengdu Di Yi Pharmaceutical Co., Ltd. romanized620
7Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized610
8Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized530
9Intas Pharmaceuticals. Ltd.510
10Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510

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

105 this week

AcceptedDrugApplicants
2023/07/19Generic · Class 3 Minoxidil LinimentCYHS2301940 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/19Generic · Class 3 Minoxidil LinimentCYHS2301939 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/19Generic · Class 3 Piracetam InjectionCYHS2301938 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/07/19Generic · Class 3 Piracetam InjectionCYHS2301937 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2023/07/19New drug · Class 1.1 双参宁心胶囊 · No verified English nameCXZL2300049 Zhongguo Zhong Yi Ke College Xi Yuan Hospital romanized
2023/07/19New drug · Class 1.1 小儿健脾颗粒 · No verified English nameCXZL2300048 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2023/07/19New drug · Class 2.5 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2300054 Changchun Zhuo Yi Bio Co., Ltd. romanized
2023/07/19New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300053 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2023/07/19New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2300052 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/19New drug · Class 1 HH-006注射液 · No verified English nameCXSL2300496 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2023/07/19New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2300495 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized
2023/07/19New drug · Class 1 SHR-2022注射液 · No verified English nameCXSL2300494 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/07/19New drug · Class 1 SKG0106眼内注射溶液 · No verified English nameCXSL2300493 Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2023/07/19New drug · Class 2.4 Chidamide TabletsCXHS2300061 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Shenzhen Wei Xin Pharma Co., Ltd. romanized
2023/07/19New drug · Class 1 MT-001胶囊 · No verified English nameCXHL2300798 Zhejiang Mai Tong Biopharmaceuticals Co., Ltd. romanized
2023/07/19New drug · Class 1 MT-001胶囊 · No verified English nameCXHL2300797 Zhejiang Mai Tong Biopharmaceuticals Co., Ltd. romanized
2023/07/19New drug · Class 1 HYP-2090PTSA胶囊 · No verified English nameCXHL2300796 Name not romanized
2023/07/19New drug · Class 1 吸入用HTPEP-001 · No verified English nameCXHL2300795 Chengdu Hui Tai Biopharmaceuticals Co., Ltd. romanized
2023/07/18Import · Class 1 HFB200301注射液 · No verified English nameJXSL2300130 HiFiBiO Inc.; HiFiBiO (Hangzhou) Co. Ltd
2023/07/18Import · Class 1 AZD9833片 · No verified English nameJXHL2300170 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/07/18Import · Class 1 瑞普替尼胶囊 · No verified English nameJXHL2300169 Bristol-Myers Squibb Company
2023/07/18Import · Class 1 瑞普替尼胶囊 · No verified English nameJXHL2300168 Bristol-Myers Squibb Company
2023/07/18Import · Class 1 INCB099280片 · No verified English nameJXHL2300167 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2023/07/18Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHS2301936 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2301935 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2301932 Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.
2023/07/18Generic · Class 3 Diprophylline InjectionCYHS2301931 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/07/18Generic · Class 3 Indobufen TabletsCYHS2301929 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Indobufen TabletsCYHS2301928 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Multiple Vitamins InjectionCYHS2301923 Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD

75 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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