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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 475 drug applications between 4 November 2026 and 10 November 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 81, covering 52 drug names.

2026/11/04 – 2026/11/10

Period
2026/11/04 to 2026/11/10, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
475
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
475

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

475filings, 81 of them generic

By application type

Application typeFilings
Supplement252
Generic81
New drug77
Import54
Import re-registration10
Unspecified1

By drug type

Drug typeFilings
Chemical drug259
TCM112
Therapeutic biologic95
Prophylactic biologic6
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

52 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

287 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1230
2Novo Nordisk A/S1010
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized650
4Pfizer Inc.630
5F. Hoffmann-La Roche Ltd610
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
7AstraZeneca AB530
8Chengdu Shuo De Pharma Co., Ltd. romanized531
9Yi Chang Ren Fu Pharma Co., Ltd. romanized523
10MyoKardia Inc.510

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

Entered review this week
485
Left the under-review list this week
515

Of these, NMPA published approval-document delivery for 279 (including 264 supplemental applications, not counted as new marketing approvals) and notification delivery for 17; the outcome of the other 219 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1AstraZeneca AB64
2Liaoning Min Kang Pharmaceutical Co., Ltd. romanized62
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.55
4Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized54
5Novo Nordisk A/S51
6Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized44
7Sichuan Tai Le Pharmaceutical Co., Ltd. romanized44
8Hubei Dong Xin Pharma Co., Ltd. romanized44
9Jiangxi Shimei Pharmaceutical Co., Ltd42
10Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized42

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Amgen Inc.123
2AstraZeneca AB105
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized77
4Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized65
5Pfizer Inc.63
6MyoKardia Inc.51
7Novo Nordisk A/S51
8Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized51
9Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized51
10Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized44

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

153 this week

AcceptedDrugApplicants
2026/11/10Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600109 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/10Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600108 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/10Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600107 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/10Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600106 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/10Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600105 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/10Import · Class 1 GSK3862995B注射液 · No verified English nameJXSL2600310 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600505 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600504 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600503 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600502 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600501 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600500 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/11/10Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2602766 Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
2026/11/10Generic · Class 3 Calcium Carbonate TabletsCYHS2602759 Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2026/11/10New drug · Class 1 BR1A101注射液 · No verified English nameCXSL2601251 Zhong Ke Bai Rui (Changchun) Bio Technology Co., Ltd. romanized
2026/11/10New drug · Class 1 注射用DR510 · No verified English nameCXSL2601250 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2026/11/10New drug · Class 1 GSK5784283注射液 · No verified English nameCXSL2601249 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2026/11/10New drug · Class 1 PRBT001注射液 · No verified English nameCXSL2601248 Pan Ru Bio Technology (Tianjin) Co., Ltd. romanized
2026/11/10New drug · Class 1 Zoldonrasib片 · No verified English nameCXHL2601391 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2026/11/10New drug · Class 2.2 BCM1139 · No verified English nameCXHL2601390 Hubei Mei Lin Pharma Co., Ltd. romanized
2026/11/10New drug · Class 2.4 Glycopyrrolate InjectionCXHL2601389 Guangdong Jia Bo Pharmaceutical Co., Ltd. romanized
2026/11/10New drug · Class 2.2 EP-0330SP · No verified English nameCXHL2601388 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/11/10New drug · Class 2.2 EP-0330SP · No verified English nameCXHL2601387 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/11/10New drug · Class 2.2 EP-0330SP · No verified English nameCXHL2601386 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/11/09Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600104 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd.
2026/11/09Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600103 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd.
2026/11/09Import · Class 1 AZD0299 · No verified English nameJXSL2600309 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd
2026/11/09Import · Class 2.2 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2600308 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2026/11/09Import · Class 1 BI 3822971 注射液 · No verified English nameJXSL2600307 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/11/09Import · Class 1 Efruxifermin注射用冻干粉 · No verified English nameJXSL2600306 Akero Therapeutics Inc.; ICON Clinical Research (Beijing No. 2) Co. Ltd.

123 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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