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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 481 drug applications between 30 October 2026 and 5 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 51 drug names.

2026/10/30 – 2026/11/05

Period
2026/10/30 to 2026/11/05, 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
481
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
481

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

481filings, 69 of them generic

By application type

Application typeFilings
Supplement237
New drug108
Generic69
Import49
Import re-registration16
Unspecified2

By drug type

Drug typeFilings
Chemical drug241
TCM146
Therapeutic biologic86
Prophylactic biologic5
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piperacillin Sodium for Injection3116
2Metformin Hydrochloride Extended-release Tablets3110
3Emedastine Difumarate Eye Drops229
4氟比洛芬凝胶贴膏 · No verified English name2216
5氧 · No verified English name2215
6Mirogabalin Besilate Tablets2261
7蒙脱石混悬液 · No verified English name2231
8Apalutamide Tablets2218
9复方氨基酸注射液(17AA-SF) · No verified English name214
10Dotinurad Tablets2155

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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.1230
2Eli Lilly and Company910
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized770
4AstraZeneca AB740
5Fresenius Kabi AB720
6Hebei Wan Sui Pharma Co., Ltd. romanized660
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
8Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
9MUNDIPHARMA GmbH610
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530

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
441
Left the under-review list this week
511

Of these, NMPA published approval-document delivery for 280 (including 274 supplemental applications, not counted as new marketing approvals) and notification delivery for 22; the outcome of the other 209 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
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.88
3AstraZeneca AB85
4Novo Nordisk A/S82
5Topfond Pharmaceutical Co., Ltd.66
6Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized55
7Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized54
8Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized52
9Shanghai Lei Yun Shang Pharma Co., Ltd. romanized44
10Shanxi Ao Er Pharma Co., Ltd. romanized44

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Eli Lilly and Company91
2Sichuan Xin Da Kang Pharma Co., Ltd. romanized77
3AstraZeneca AB74
4Fresenius Kabi AB72
5Hebei Wan Sui Pharma Co., Ltd. romanized66
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized66
7MUNDIPHARMA GmbH61
8Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized61
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized53
10Amgen Inc.52

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

177 this week

AcceptedDrugApplicants
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.
2026/11/05Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2600486 MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/11/05Import · Class 2.4 Mavacamten胶囊 · No verified English nameJXHL2600485 MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/11/05Generic · Class 3 Indocyaninegreen for InjectionCYHS2602723 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/11/05Generic · Class 3 Calcitriol Oral SolutionCYHS2602719 Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2026/11/05Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2602711 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2026/11/05Generic · Class 3 Piperacillin Sodium for InjectionCYHS2602709 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/11/05Generic · Class 3 Piperacillin Sodium for InjectionCYHS2602708 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/11/05Generic · Class 3 Piperacillin Sodium for InjectionCYHS2602707 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/11/05Generic · Class 3 Oxaliplatin InjectionCYHS2602705 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/11/05Generic · Class 3 Oxaliplatin InjectionCYHS2602703 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/11/05New drug · Class 3.4 人血白蛋白 · No verified English nameCXSS2600185 Guangxi Lai Shi Biopharmaceutical Co., Ltd. romanized
2026/11/05New drug · Class 1 BJ047注射液(皮下注射) · No verified English nameCXSL2601233 Shanghai Bao Ji Pharma Co., Ltd. romanized
2026/11/05New drug · Class 3.4 静注人免疫球蛋白 · No verified English nameCXSL2601232 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized
2026/11/05New drug · Class 1 注射用HMPL-A177 · No verified English nameCXSL2601231 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/11/05New drug · Class 1 IBI3019 · No verified English nameCXSL2601230 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/11/05New drug · Class 1 QLS2409注射液 · No verified English nameCXSL2601229 Qilu Pharmaceutical Co., Ltd.

147 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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