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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 284 drug applications between 16 November 2024 and 22 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 66 drug names.

2024/11/16 – 2024/11/22

Period
2024/11/16 to 2024/11/22, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
5

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

284filings, 80 of them generic

By application type

Application typeFilings
Supplement119
Generic80
New drug53
Import14
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug222
Therapeutic biologic32
TCM26
Prophylactic biologic4

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Oxybuprocaine Hydrochloride Eye Drops2210
3Glucosamine Sulfate Capsules2251
4西甲硅油乳剂 · No verified English name223
5Adapalene Gel2230
6Lamotrigine Tablets210
7Metformin Hydrochloride Oral Solution213
8Lidocaine Hydrochloride Topical Solution210
9Ambroxol Hydrochloride Oral Solution2146
10Nitroglycerin Injection217

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

182 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1360
2Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized650
3Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized610
4Novo Nordisk A/S510
5Wan Bang De Pharmaceutical Group Co., Ltd. romanized440
6Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized440
7Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized440
8Eli Lilly Nederland B.V.410
9Janssen Research & Development LLC320
10Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized323

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

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

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

95 this week

AcceptedDrugApplicants
2024/11/22Import · Class 3.1 特泽利尤单抗注射液 · No verified English nameJXSS2400103 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2024/11/22Import · Class 3.1 特泽利尤单抗注射液 · No verified English nameJXSS2400102 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2024/11/22Import · Class 1 MK-7240注射液 · No verified English nameJXSL2400225 Merck Sharp & Dohme LLC; Name not romanized
2024/11/22Generic · Class 3 盐酸尼卡地平氯化钠注射液 · No verified English nameCYHS2404016 Zhejiang Guo Jing Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/11/22Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2404015 HAINAN HUALON PHARMACEUTICAL CO.,LTD
2024/11/22Generic · Class 3 Colchicine TabletsCYHS2404014 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2024/11/22Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2404011 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2024/11/22Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2404010 Anhui Rui Qi Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/11/22Generic · Class 3 Aminophylline InjectionCYHS2404009 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/11/22Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2404008 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2024/11/22Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2404007 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2024/11/22New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2400126 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized
2024/11/22New drug · Class 1.4 重组二价肠道病毒疫苗(汉逊酵母) · No verified English nameCXSL2400791 Wei Er Tai Ke (Beijing) Bio Technology Co., Ltd. romanized
2024/11/22New drug · Class 1 HT-102注射液 · No verified English nameCXSL2400790 Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized
2024/11/22New drug · Class 1 TY-2699a胶囊 · No verified English nameCXHL2401272 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2024/11/22New drug · Class 1 TY-2699a胶囊 · No verified English nameCXHL2401271 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2024/11/22New drug · Class 1 HT-101注射液 · No verified English nameCXHL2401270 Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized
2024/11/21Import · Class 2.4 Adagrasib 片 · No verified English nameJXHL2400270 Mirati Therapeutics Inc. a Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/11/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2404003 Kai Feng Kang Nuo Pharma Co., Ltd. romanized
2024/11/21Generic · Class 3 Sulindac TabletsCYHS2404001 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Sulindac TabletsCYHS2404000 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2403996 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2403992 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/11/21Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2403991 Anhui Pioneer Pharmaceutical Co., Ltd
2024/11/21Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2403986 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403983 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403981 Hainan Shuang Cheng Pharma Co., Ltd. romanized
2024/11/21Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403980 Beijing Kang Er Fu Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHL2400231 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized
2024/11/21Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHL2400230 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized

65 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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