YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 492 drug applications between 17 July 2026 and 23 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 48 drug names.

2026/07/17 – 2026/07/23

Period
2026/07/17 to 2026/07/23, 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
492
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
162

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

492filings, 71 of them generic

By application type

Application typeFilings
Supplement308
New drug72
Generic71
Import26
Unspecified11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug224
TCM172
Therapeutic biologic82
Prophylactic biologic11
Biologic3

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

48 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

280 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1720
2Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized1090
3Jilin Ji Er Ji Pharma Co., Ltd. romanized880
4Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized770
5Merck Sharp & Dohme LLC740
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
7Fresenius Kabi Austria GmbH610
8Shanxi Hua Kang Pharma Co., Ltd. romanized540
9Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized540
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520

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

114 this week

AcceptedDrugApplicants
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
2026/07/23New drug · Class 2.3 舒筋健腰丸 · No verified English nameCXZL2600063 Guangzhou Bai Yun Shan Chen Li Ji Pharmaceutical Factory Co., Ltd. romanized
2026/07/23New drug · Class 1 HX15001注射液 · No verified English nameCXSL2600768 Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized
2026/07/23New drug · Class 1 HXN5003注射液 · No verified English nameCXSL2600767 Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized
2026/07/23New drug · Class 2.2 注射用埃普奈明 · No verified English nameCXSL2600766 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2026/07/23New drug · Class 1 注射用LM-364 · No verified English nameCXSL2600765 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/07/23New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600764 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/23New drug · Class 2.4 盐酸伊立替康脂质体注射液(Ⅱ) · No verified English nameCXHS2600106 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/07/23New drug · Class 2.4 HS-10561胶囊 · No verified English nameCXHL2600897 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/23New drug · Class 2.2 TH5213 · No verified English nameCXHL2600896 Jilin Tian Heng Pharma Co., Ltd. romanized
2026/07/23New drug · Class 2.2 TH5213 · No verified English nameCXHL2600895 Jilin Tian Heng Pharma Co., Ltd. romanized
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600068 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600067 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600066 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600065 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600064 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 NN2802 · No verified English nameJXSL2600174 NOVELTY NOBILITY Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/07/22Import · Class 1 MK-1084片 · No verified English nameJXHL2600284 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/22Import · Class 1 MK-1084片 · No verified English nameJXHL2600283 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/22Generic · Class 3 Colistimethate Sodium for InjectionCYHS2601762 Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/07/22Generic · Class 3 Ferrous Succinate TabletsCYHS2601757 Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized
2026/07/22New drug · Class 1 注射用BL-M12D1 · No verified English nameCXSL2600763 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/07/22New drug · Class 1 SYS6055注射液 · No verified English nameCXSL2600762 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600761 Gan Li Pharma Shandong Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600760 Gan Li Pharma Shandong Co., Ltd. romanized

84 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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