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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 346 drug applications between 10 November 2026 and 16 November 2026 (data as of 15 November 2026 06:00). Of these, generic applications numbered 56, covering 38 drug names.

2026/11/10 – 2026/11/16

Period
2026/11/10 to 2026/11/16, 7 days inclusive
Data as of
2026/11/15 06:00
Cached records
94,880 acceptance records, 11,553 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
346
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
346

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

346filings, 56 of them generic

By application type

Application typeFilings
Supplement178
New drug77
Generic56
Import27
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug189
TCM89
Therapeutic biologic56
Biologic5
Prophylactic biologic5
Unspecified2

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Fosfomycin Sodium For Injection3116
3西诺氨酯片 · No verified English name3124
4Tafluprost Eye Drops223
5Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets212
6Ethyl Iosapentate Capsules2125
7Ibuprofen Injection218
8Hydrocortisone Tablets212
9Vortioxetine Hydrobromide Tablets2110
10Pemetrexed Disodium for Injection214

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

209 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized840
2F. Hoffmann-La Roche Ltd820
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
8Eli Lilly and Company520
9Novo Nordisk A/S510
10Anhui Sheng Jing Cheng Hui Yao Pharma Co., Ltd. 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
440
Left the under-review list this week
403

Of these, NMPA published approval-document delivery for 130 (including 126 supplemental applications, not counted as new marketing approvals) and notification delivery for 7; the outcome of the other 266 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
2AbbVie Inc.81
3Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized71
4Sichuan Pharmaceutical Formulations Co., Ltd. romanized63
5Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized62
6Liaoning Min Kang Pharmaceutical Co., Ltd. romanized62
7Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized51
8Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized44
9Merck Sharp & Dohme LLC43
10TIANJIN LISHENG PHARMACEUTICAL CO., LTD42

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized84
2F. Hoffmann-La Roche Ltd82
3Yi Chang Ren Fu Pharma Co., Ltd. romanized73
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized73
5CISEN PHARMACEUTICAL CO., LTD.63
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized61
7Suzhou Ya Sheng Pharma Co., Ltd. romanized61
8Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized55
9Chengdu Shuo De Pharma Co., Ltd. romanized53
10Eli Lilly and Company52

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

117 this week

AcceptedDrugApplicants
2026/11/13Import · Class 1 4D-150玻璃体内注射液 · No verified English nameJXSL2600315 4D Molecular Therapeutics Inc.; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2026/11/13Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600510 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/11/13Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600509 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/11/13Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600508 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/11/13Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600507 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/11/13Generic · Class 3 琥珀酸亚铁散剂 · No verified English nameCYHS2602808 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2026/11/13Generic · Class 3 Atropine Sulfate InjectionCYHS2602807 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/11/13Generic · Class 3 Atropine Sulfate InjectionCYHS2602806 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/11/13New drug · Class 2.4 注射用重组A型肉毒毒素(150 kD) · No verified English nameCXSS2600187 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2026/11/13New drug · Class 1 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601273 Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized
2026/11/13New drug · Class 1 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601272 Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized
2026/11/13New drug · Class 1 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601271 Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized
2026/11/13New drug · Class 1 AK135注射液 · No verified English nameCXSL2601270 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/11/13New drug · Class 1 MS8031注射液 · No verified English nameCXSL2601269 Ningbo Mei Sai Biopharmaceuticals Technology Co., Ltd. romanized
2026/11/13New drug · Class Unmapped source value 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601268 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2026/11/13New drug · Class Unmapped source value 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601267 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2026/11/13New drug · Class Unmapped source value 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601266 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2026/11/13New drug · Class Unmapped source value 度普利尤单抗注射液 · No verified English nameCXSL2601265 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2026/11/13New drug · Class 1 SKB575(HBM7575)注射液 · No verified English nameCXSL2601264 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/11/13New drug · Class 1 HW060015胶囊 · No verified English nameCXHL2601433 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2026/11/13New drug · Class 1 HW060015胶囊 · No verified English nameCXHL2601432 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2026/11/13New drug · Class 1 LG-1057片 · No verified English nameCXHL2601431 Lin Gang Guo Jia Laboratory romanized
2026/11/13New drug · Class 1 LG-1057片 · No verified English nameCXHL2601430 Lin Gang Guo Jia Laboratory romanized
2026/11/13New drug · Class 1 LG-1057片 · No verified English nameCXHL2601429 Lin Gang Guo Jia Laboratory romanized
2026/11/13New drug · Class 1 KR25102片 · No verified English nameCXHL2601428 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/11/13New drug · Class 1 CS231295片 · No verified English nameCXHL2601427 Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2026/11/13New drug · Class 1 CS231295片 · No verified English nameCXHL2601426 Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2026/11/13New drug · Class 1 CS231295片 · No verified English nameCXHL2601425 Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
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

87 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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