YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 425 drug applications between 31 August 2026 and 6 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 44 drug names.

2026/08/31 – 2026/09/06

Period
2026/08/31 to 2026/09/06, 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
425
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
320

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

425filings, 56 of them generic

By application type

Application typeFilings
Supplement238
New drug76
Generic56
Import40
Import re-registration10
Unspecified5

By drug type

Drug typeFilings
Chemical drug195
TCM146
Therapeutic biologic80
Prophylactic biologic4

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

244 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Inc.810
2Gan Li Pharma Shandong Co., Ltd. romanized810
3Novartis Pharma AG740
4F. Hoffmann-La Roche Ltd720
5Pfizer Inc.640
6AstraZeneca AB620
7Changchun Jin Sai Pharma Co., Ltd. romanized620
8Beijing Kang Di Ni Pharma Co., Ltd. romanized550
9Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized550
10Haerbin Zhen Bao Pharmaceutical 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

133 this week

AcceptedDrugApplicants
2026/09/04Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600239 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/04Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600238 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/04Import · Class 1 FUB523注射液 · No verified English nameJXSL2600237 Novartis Pharma AG
2026/09/04Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600397 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/04Import · Class 2.4 Zavegepant鼻喷雾剂 · No verified English nameJXHL2600396 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/04Import · Class 1 MK-1084片 · No verified English nameJXHL2600395 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/09/04Import · Class 1 MK-1084片 · No verified English nameJXHL2600394 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/09/04Generic · Class 3 Simethicone Chewable TabletsCYHS2602208 Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/09/04Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2602206 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2026/09/04Generic · Class 3 Dexmethylphenidate Hydrochloride TabletsCYHL2600095 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2026/09/04New drug · Class 3.2 注射用人促甲状腺素β · No verified English nameCXSS2600145 Name not romanized
2026/09/04New drug · Class 1 注射用NCB005 · No verified English nameCXSL2600962 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2026/09/04New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600961 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/04New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600960 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/04New drug · Class 1 注射用 B024 · No verified English nameCXSL2600959 Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized
2026/09/04New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2601079 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/04New drug · Class 1 BW-20507-2注射液 · No verified English nameCXHL2601078 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2026/09/04New drug · Class 1 KC1101片 · No verified English nameCXHL2601077 Beijing Kang Chen Pharma Co., Ltd. romanized
2026/09/04New drug · Class 1 KC1101片 · No verified English nameCXHL2601076 Beijing Kang Chen Pharma Co., Ltd. romanized
2026/09/04New drug · Class 1 KC1101片 · No verified English nameCXHL2601075 Beijing Kang Chen Pharma Co., Ltd. romanized
2026/09/04New drug · Class 1 ZN-F-6418胶囊 · No verified English nameCXHL2601074 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2026/09/04New drug · Class 1 ZN-F-6418胶囊 · No verified English nameCXHL2601073 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2026/09/04New drug · Class 1 IN10018片 · No verified English nameCXHL2601072 Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized
2026/09/04New drug · Class 1 IN10018片 · No verified English nameCXHL2601071 Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized
2026/09/03Import · Class 1 伐米奇拜单抗注射液 · No verified English nameJXSS2600089 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/09/03Import · Class 3.1 西妥昔单抗注射液 · No verified English nameJXSS2600088 Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd.
2026/09/03Import · Class 1 Budoprutug注射液 · No verified English nameJXSL2600236 Climb Bio Inc.; Beijing Mabworks Biotech Company Limited
2026/09/03Import · Class 1 EDK060 · No verified English nameJXHL2600393 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/03Import · Class 1 verducatib 片 · No verified English nameJXHL2600392 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/09/03Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2602204 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized

103 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.