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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 484 drug applications between 3 November 2026 and 9 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 55 drug names.

2026/11/03 – 2026/11/09

Period
2026/11/03 to 2026/11/09, 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
484
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
484

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

484filings, 81 of them generic

By application type

Application typeFilings
Supplement246
New drug94
Generic81
Import47
Import re-registration15
Unspecified1

By drug type

Drug typeFilings
Chemical drug247
TCM125
Therapeutic biologic103
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

55 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

294 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1230
2AstraZeneca AB1050
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized770
4Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized650
5Pfizer Inc.630
6MyoKardia Inc.510
7Novo Nordisk A/S510
8Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
9Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized510
10Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized440

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
492
Left the under-review list this week
574

Of these, NMPA published approval-document delivery for 350 (including 335 supplemental applications, not counted as new marketing approvals) and notification delivery for 20; the outcome of the other 204 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized1010
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.88
3Topfond Pharmaceutical Co., Ltd.66
4Hubei Dong Xin Pharma Co., Ltd. romanized66
5Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized65
6AstraZeneca AB64
7Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized55
8Novo Nordisk A/S51
9Shanghai Lei Yun Shang Pharma Co., Ltd. romanized44
10Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized44

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Amgen Inc.123
2AstraZeneca AB94
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized77
4Pfizer Inc.74
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized74
6Hebei Wan Sui Pharma Co., Ltd. romanized66
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized66
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized53
9MyoKardia Inc.51
10Novo Nordisk A/S51

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

165 this week

AcceptedDrugApplicants
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.
2026/11/09Import · Class 2.4 艾曲帕米鼻喷雾剂 · No verified English nameJXHL2600498 Milestone Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd.
2026/11/09Import · Class 2.4 盐酸索安非托片 · No verified English nameJXHL2600497 AXSOME MALTA LTD.; Ignis Therapeutics (Suzhou) Limited
2026/11/09Generic · Class 3 Atropine Sulfate InjectionCYHS2602756 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2026/11/09Generic · Class 3 Atropine Sulfate InjectionCYHS2602755 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2026/11/09Generic · Class 3 Ibuprofen InjectionCYHS2602751 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2026/11/09Generic · Class 3 Ibuprofen InjectionCYHS2602750 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2026/11/09Generic · Class 3 布美他尼片 · No verified English nameCYHS2602749 Zhejiang Hao Ge Pharma Co., Ltd. romanized
2026/11/09Generic · Class 3 Brivaracetam Oral SolutionCYHS2602747 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/11/09Generic · Class 3 Brivaracetam TabletsCYHS2602745 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/11/09Generic · Class 3 Brivaracetam TabletsCYHS2602744 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/11/09Generic · Class 3 Brivaracetam TabletsCYHS2602743 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/11/09Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2602733 Hunan Wei Te Pharmaceutical Co., Ltd. romanized
2026/11/09New drug · Class 1 注射用BG-T0920 · No verified English nameCXSL2601247 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/11/09New drug · Class 1 KT501注射液 · No verified English nameCXSL2601246 Kai Lin Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/11/09New drug · Class 1 注射用CS5006 · No verified English nameCXSL2601245 Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2026/11/09New drug · Class 1 注射用BCT-001 · No verified English nameCXSL2601244 Shanghai Ba Kang Lian Yao Biopharmaceuticals Technology Co., Ltd. romanized
2026/11/09New drug · Class 1 SR604注射液 · No verified English nameCXSL2601243 Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized
2026/11/09New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2601242 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/11/09New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2601241 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/11/09New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2601240 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/11/09New drug · Class 1 IL17A纳米抗体基因修饰干细胞注射液 · No verified English nameCXSL2601239 Beijing Bei Lai Bio Technology Co., Ltd. romanized
2026/11/09New drug · Class 2.3 EP-0170T(Ⅰ) · No verified English nameCXHS2600152 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/11/09New drug · Class 2.4 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHS2600151 Qilu Pharmaceutical Co., Ltd.
2026/11/09New drug · Class 2.4 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHS2600150 Qilu Pharmaceutical Co., Ltd.

135 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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