YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 366 drug applications between 7 November 2026 and 13 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 43 drug names.

2026/11/07 – 2026/11/13

Period
2026/11/07 to 2026/11/13, 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
366
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
366

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

366filings, 72 of them generic

By application type

Application typeFilings
Supplement181
New drug74
Generic72
Import31
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug206
TCM84
Therapeutic biologic68
Biologic4
Unspecified2
Prophylactic biologic2

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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Ibuprofen Injection428
3Polyvinyl Alcohol Eye Drops3224
4Brivaracetam Tablets3119
5Fosfomycin Sodium For Injection3116
6Mirogabalin Besilate Tablets3161
7西诺氨酯片 · No verified English name3124
8Tafluprost Eye Drops223
9Ertugliflozin Tablets2213
10Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets212

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

228 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1F. Hoffmann-La Roche Ltd820
2Yi Chang Ren Fu Pharma Co., Ltd. romanized735
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
4CISEN PHARMACEUTICAL CO., LTD.633
5Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
6Suzhou Ya Sheng Pharma Co., Ltd. romanized610
7Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized550
8Chengdu Shuo De Pharma Co., Ltd. romanized531
9Novo Nordisk A/S510
10Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized420

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
444
Left the under-review list this week
292

Of these, NMPA published approval-document delivery for 48 (including 48 supplemental applications, not counted as new marketing approvals) and notification delivery for 5; the outcome of the other 239 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized82
2Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized71
3Sichuan Pharmaceutical Formulations Co., Ltd. romanized63
4Liaoning Min Kang Pharmaceutical Co., Ltd. romanized62
5Novo Nordisk A/S51
6Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized51
7Merck Sharp & Dohme LLC43
8TIANJIN LISHENG PHARMACEUTICAL CO., LTD42
9NAPP PHARMACEUTICALS LIMITED41
10Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized33

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1F. Hoffmann-La Roche Ltd82
2Yi Chang Ren Fu Pharma Co., Ltd. romanized73
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized73
4CISEN PHARMACEUTICAL CO., LTD.63
5Shenzhen Xin Li Tai Pharma Co., Ltd. romanized61
6Suzhou Ya Sheng Pharma Co., Ltd. romanized61
7Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized55
8AstraZeneca AB53
9Chengdu Shuo De Pharma Co., Ltd. romanized53
10Pfizer 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

124 this week

AcceptedDrugApplicants
2026/11/12Import · Class 1 MAR001 · No verified English nameJXSL2600314 Marea Therapeutics Inc.; Beijing MEDPACE Pharmaceuticals Technology Co., Ltd. romanized
2026/11/12Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2602792 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/11/12Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2602791 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/11/12Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHS2602790 Jiangsu Hua Yi He Pharmaceuticals Co., Ltd. romanized
2026/11/12Generic · Class 3 Hydrocortisone TabletsCYHS2602788 Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/11/12Generic · Class 3 Hydrocortisone TabletsCYHS2602786 Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/11/12Generic · Class 3 Bilastine Oral SolutionCYHS2602781 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/11/12New drug · Class 1 IBI354 · No verified English nameCXSL2601263 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2026/11/12New drug · Class 1 EDP004注射液 · No verified English nameCXSL2601262 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/11/12New drug · Class 2.2 帕博利珠单抗注射液 · No verified English nameCXSL2601261 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/11/12New drug · Class 1 注射用VRT106 · No verified English nameCXSL2601260 Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized
2026/11/12New drug · Class 1 YSC001注射液 · No verified English nameCXSL2601259 Yan Sheng Chao (Beijing) Bio Technology Co., Ltd. romanized
2026/11/12New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK 细胞) · No verified English nameCXSL2601258 Guangzhou Shi Jia He Bio Technology Co., Ltd. romanized
2026/11/12New drug · Class 1 注射用依康坦博妥塔单抗 · No verified English nameCXSL2601257 Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2026/11/12New drug · Class 1 注射用奥丁安妥拜单抗 · No verified English nameCXSL2601256 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2026/11/12New drug · Class 1 GR2304注射液(皮下注射) · No verified English nameCXSL2601255 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/11/12New drug · Class 1 注射用BAT8013 · No verified English nameCXSL2601254 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/11/12New drug · Class Unmapped source value CZ025 · No verified English nameCXHL2601424 Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2026/11/12New drug · Class Unmapped source value CZ025 · No verified English nameCXHL2601423 Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2026/11/12New drug · Class 1 RO7673396薄膜包衣片 · No verified English nameCXHL2601422 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2026/11/12New drug · Class 1 RO7673396薄膜包衣片 · No verified English nameCXHL2601421 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2026/11/12New drug · Class 1 ACT001胶囊 · No verified English nameCXHL2601420 Xin Yi Shang De Yao Yuan Pharma Co., Ltd. romanized
2026/11/12New drug · Class Unmapped source value 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601419 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2026/11/12New drug · Class Unmapped source value 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601418 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2026/11/12New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601417 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2026/11/12New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601416 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized
2026/11/12New drug · Class 1 APG-3288片 · No verified English nameCXHL2601415 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2026/11/12New drug · Class 1 APG-3288片 · No verified English nameCXHL2601414 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2026/11/12New drug · Class 1 APG-3288片 · No verified English nameCXHL2601413 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2026/11/12New drug · Class Unmapped source value CYH33干混悬剂 · No verified English nameCXHL2601412 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized

94 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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