YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 490 drug applications between 2 November 2026 and 8 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 52 drug names.

2026/11/02 – 2026/11/08

Period
2026/11/02 to 2026/11/08, 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
490
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
490

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

490filings, 66 of them generic

By application type

Application typeFilings
Supplement255
New drug115
Generic66
Import39
Import re-registration14
Unspecified1

By drug type

Drug typeFilings
Chemical drug241
TCM141
Therapeutic biologic99
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

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection3116
2Metformin Hydrochloride Extended-release Tablets3110
3Edaravone and Dexborneol Concentrated Solution for Injection2234
4Dotinurad Tablets2155
5Oxaliplatin Injection214
6对乙酰氨基酚颗粒 · No verified English name212
7帕拉米韦氯化钠注射液 · No verified English name2117
8注射用盐酸地尔硫? · No verified English nameThe source text contains a character that cannot be displayed.219
9注射用磷酸左奥硝唑酯二钠 · No verified English name2122
10Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules212

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

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1230
2AstraZeneca AB940
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized770
4Pfizer Inc.740
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized740
6Hebei Wan Sui Pharma Co., Ltd. romanized660
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
9MyoKardia Inc.510
10Novo Nordisk A/S510

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
569

Of these, NMPA published approval-document delivery for 346 (including 327 supplemental applications, not counted as new marketing approvals) and notification delivery for 21; the outcome of the other 202 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. romanized1212
2Novo Nordisk A/S82
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.77
4Topfond Pharmaceutical Co., Ltd.66
5Hubei Dong Xin Pharma Co., Ltd. romanized66
6Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized65
7AstraZeneca AB64
8Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized55
9Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized52
10Shanghai Lei Yun Shang 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

173 this week

AcceptedDrugApplicants
2026/11/06Generic · Class 3 罗沙司他片 · No verified English nameCYHS2602731 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2026/11/06Generic · Class 3 Potassium Chloride InjectionCYHS2602728 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2026/11/06Generic · Class 3 Folic Acid TabletsCYHS2602725 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2026/11/06Generic · Class 3 Lidocaine and Prilocaine Periodontal GelCYHL2600127 Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized
2026/11/06New drug · Class 3.4 治疗用卡介苗 · No verified English nameCXSS2600186 Chengdu Ke En Bio Technology Co., Ltd. romanized
2026/11/06New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2601238 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2026/11/06New drug · Class 1 注射用HBT-708 · No verified English nameCXSL2601237 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/11/06New drug · Class 1 GR2303注射液 · No verified English nameCXSL2601236 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/11/06New drug · Class 1 GR2303注射液 · No verified English nameCXSL2601235 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/11/06New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2601234 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/11/06New drug · Class 1 YH601软膏 · No verified English nameCXHL2601381 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/11/06New drug · Class 1 YH601软膏 · No verified English nameCXHL2601380 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/11/06New drug · Class 1 LNK01001缓释片 · No verified English nameCXHL2601379 Ling Ke Pharma (Zhejiang) Co., Ltd. romanized
2026/11/06New drug · Class 1 SNH-126988胶囊 · No verified English nameCXHL2601378 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2026/11/06New drug · Class 1 SNH-126988胶囊 · No verified English nameCXHL2601377 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2026/11/06New drug · Class 1 SNH-126988胶囊 · No verified English nameCXHL2601376 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2026/11/05Import · Class 3.1 马塔西单抗注射液 · No verified English nameJXSS2600102 Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd.
2026/11/05Import · Class 1 PAC001 注射液 · No verified English nameJXSL2600305 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/11/05Import · Class 1 PAC001 注射液 · No verified English nameJXSL2600304 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/11/05Import · Class 2.2 Panitumumab · No verified English nameJXSL2600303 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600496 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600495 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600494 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600493 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600492 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 1 AMG 410 · No verified English nameJXHL2600491 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/05Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2600490 MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/11/05Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2600489 MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/11/05Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2600488 MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/11/05Import · Class 2.4 Pemafibrate缓释片 · No verified English nameJXHL2600487 Kowa Company Ltd.; Hangzhou Tigermed Consulting Co. Ltd.

143 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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