YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 486 drug applications between 27 June 2026 and 3 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 46 drug names.

2026/06/27 – 2026/07/03

Period
2026/06/27 to 2026/07/03, 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
486
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
123

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

486filings, 71 of them generic

By application type

Application typeFilings
Supplement298
Generic71
New drug55
Import34
Unspecified17
Import re-registration11

By drug type

Drug typeFilings
Chemical drug240
TCM196
Therapeutic biologic43
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

46 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

291 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized25140
2AstraZeneca AB1530
3Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized770
4Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized660
5Shandong Xin Shi Dai Pharma Co., Ltd. romanized650
6Xizang Gan Lu Zang Yao Co., Ltd. romanized640
7Lan Yun Zhi He Bio Technology Co., Ltd. romanized550
8Bristol-Myers Squibb Company520
9Pfizer Inc.520
10Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized515

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

122 this week

AcceptedDrugApplicants
2026/07/03Import · Class 1 DS-6000a · No verified English nameJXSL2600151 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/07/03Import · Class 1 AZD5305 · No verified English nameJXHL2600257 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/07/03Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600256 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/03Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600255 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/03Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600254 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/03Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600253 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600252 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600251 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600250 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600249 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600248 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600247 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600246 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600245 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600244 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600243 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600242 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Import · Class 1 AZD6234注射液 · No verified English nameJXHL2600241 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/03Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2601584 Jiangxi Hui Ren Pharma Co., Ltd. romanized
2026/07/03Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2601583 Beijing Tai Yang Pharma Co., Ltd. romanized
2026/07/03Generic · Class 3 Acetylcysteine TabletsCYHS2601581 Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized
2026/07/03Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601580 Kang Pu Pharma Co., Ltd. romanized
2026/07/03Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601579 Kang Pu Pharma Co., Ltd. romanized
2026/07/03Generic · Class 3 Hydrotalcite SuspensionCYHS2601578 Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized
2026/07/03Generic · Class 3 Eptifibatide InjectionCYHS2601576 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2026/07/03New drug · Class 2.4 GLR1075注射液 · No verified English nameCXSL2600696 Gan Li Pharma Co., Ltd. romanized
2026/07/03New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2600695 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/03New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2600694 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/03New drug · Class 1 CM336注射液 · No verified English nameCXSL2600693 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/03New drug · Class 1 CM336注射液 · No verified English nameCXSL2600692 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized

92 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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