YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 499 drug applications between 30 June 2026 and 6 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 44 drug names.

2026/06/30 – 2026/07/06

Period
2026/06/30 to 2026/07/06, 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
499
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
124

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

499filings, 74 of them generic

By application type

Application typeFilings
Supplement313
Generic74
New drug55
Import31
Unspecified15
Import re-registration11

By drug type

Drug typeFilings
Chemical drug237
TCM209
Therapeutic biologic46
Biologic7

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

44 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

281 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized27190
2AstraZeneca AB1530
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized870
4Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized770
5Lan Yun Zhi He Bio Technology Co., Ltd. romanized770
6Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized660
7Hubei Tai Zi Pharma Co., Ltd. romanized550
8Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized530
9Qilu Pharmaceutical Co., Ltd.532
10Bristol-Myers Squibb Company520

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

127 this week

AcceptedDrugApplicants
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSS2600058 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co. Ltd.
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗 · No verified English nameJXSS2600057 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co Ltd.
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601607 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601606 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601605 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2601604 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601602 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601601 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Levothyroxine Sodium Oral SolutionCYHS2601600 Guangdong Luo Si Te Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 盐酸赛庚啶口服溶液 · No verified English nameCYHS2601597 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2601596 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601594 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601593 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601592 Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2026/07/06Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601590 Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/07/06Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601589 Tianjin Hong Ri Pharma Co., Ltd. romanized; Wuhan Ren Fu Pharma Co., Ltd. romanized
2026/07/06Generic · Class 3 Fudosteine oral solutionCYHS2601588 Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2026/07/06New drug · Class 2.1 QLM3017 · No verified English nameCXSL2600701 Qilu Pharmaceutical Co., Ltd.
2026/07/06New drug · Class 2.1 QLM3017 · No verified English nameCXSL2600700 Qilu Pharmaceutical Co., Ltd.
2026/07/06New drug · Class 1 注射用IMD2358 · No verified English nameCXSL2600699 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2026/07/06New drug · Class 1 注射用psirt3/4 DNA · No verified English nameCXSL2600698 Ai Wei Ya (Guangzhou) Pharmaceuticals Technology Co., Ltd. romanized
2026/07/06New drug · Class 1 CM529D1 · No verified English nameCXSL2600697 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/06New drug · Class 1 FXS5626片 · No verified English nameCXHL2600804 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/07/06New drug · Class 2.2 SYH9102注射液 · No verified English nameCXHL2600803 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/07/06New drug · Class 1 VV147片 · No verified English nameCXHL2600802 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/07/06New drug · Class 1 VV147片 · No verified English nameCXHL2600801 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/07/06New drug · Class 1 VV147片 · No verified English nameCXHL2600800 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/07/06New drug · Class 1 HB5凝胶 · No verified English nameCXHL2600799 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized
2026/07/06New drug · Class 1 HB5凝胶 · No verified English nameCXHL2600798 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized
2026/07/06New drug · Class 1 HB5凝胶 · No verified English nameCXHL2600797 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized

97 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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