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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 530 drug applications between 20 July 2026 and 26 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 44 drug names.

2026/07/20 – 2026/07/26

Period
2026/07/20 to 2026/07/26, 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
530
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
170

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

530filings, 63 of them generic

By application type

Application typeFilings
Supplement344
New drug76
Generic63
Import27
Unspecified15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug245
TCM186
Therapeutic biologic87
Biologic6
Prophylactic biologic6

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

297 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S2160
2Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized1090
3Merck Sharp & Dohme LLC950
4Jilin Ji Er Ji Pharma Co., Ltd. romanized880
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
7Fresenius Kabi Austria GmbH610
8Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
9Shanxi Hua Kang Pharma Co., Ltd. romanized540
10Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized540

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

113 this week

AcceptedDrugApplicants
2026/07/24Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600177 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/24Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600176 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/24Import · Class 2.4 匹妥布替尼片 · No verified English nameJXHS2600083 Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/07/24Import · Class 2.4 匹妥布替尼片 · No verified English nameJXHS2600082 Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/07/24Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2600285 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/07/24Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601775 Zhongshan Wanhan Pharmaceuticals Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/07/24New drug · Class 1 IBI3002 · No verified English nameCXSL2600773 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/24New drug · Class 1 TC-13-183细胞制剂 · No verified English nameCXSL2600772 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2026/07/24New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2600771 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized
2026/07/24New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2600770 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/24New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2600769 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/24New drug · Class 2.2 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHS2600110 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/07/24New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHS2600109 Qilu Pharmaceutical Co., Ltd.
2026/07/24New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHS2600108 Qilu Pharmaceutical Co., Ltd.
2026/07/24New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHS2600107 Qilu Pharmaceutical Co., Ltd.
2026/07/24New drug · Class 1 IBI3046注射液 · No verified English nameCXHL2600906 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/24New drug · Class 1 YR011片 · No verified English nameCXHL2600905 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/07/24New drug · Class 1 YR011片 · No verified English nameCXHL2600904 Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/07/24New drug · Class 2.2; 2.4 LS205口崩片 · No verified English nameCXHL2600903 Beijing Long Xi Bio Technology Co., Ltd. romanized
2026/07/24New drug · Class 1 TR115片 · No verified English nameCXHL2600902 Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized
2026/07/24New drug · Class 1 YY524051片 · No verified English nameCXHL2600901 Beijing Bai Yang Zhi Xin Yi Xue Research Co., Ltd. romanized
2026/07/24New drug · Class 1 YY524051片 · No verified English nameCXHL2600900 Beijing Bai Yang Zhi Xin Yi Xue Research Co., Ltd. romanized
2026/07/24New drug · Class 1 苦丁皂苷A吸入溶液 · No verified English nameCXHL2600899 Shanghai Kai Yi Pharmaceuticals Technology Co., Ltd. romanized
2026/07/24New drug · Class 2.3 BDB片 · No verified English nameCXHL2600898 Shandong Hua Su Pharmaceutical Co., Ltd. romanized
2026/07/23Import · Class 1 注射用MK-5909 · No verified English nameJXSL2600175 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/23Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2601774 Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Chengdu Ping Yuan Pharma Co., Ltd. romanized
2026/07/23Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601772 Name not romanized; Jiangsu Li Tai Er Pharma Co., Ltd. romanized
2026/07/23Generic · Class 3 Ramelteon TabletsCYHL2600083 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2026/07/23New drug · Class 1.1 CHA756丸 · No verified English nameCXZL2600065 Nuo Bei Biopharmaceuticals Technology (Shandong) Co., Ltd. romanized
2026/07/23New drug · Class 2.1; 2.2; 2.3 银杏二萜内酯滴丸 · No verified English nameCXZL2600064 Jiangsu Kang Yuan Pharma Co., Ltd. romanized

83 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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