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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 385 drug applications between 7 January 2024 and 13 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 132, covering 98 drug names.

2024/01/07 – 2024/01/13

Period
2024/01/07 to 2024/01/13, 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
385
Drugs with new generic filings (by drug name, de-duplicated)
98
Accepted this week, now under review
0

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

385filings, 132 of them generic

By application type

Application typeFilings
Supplement145
Generic132
New drug72
Import23
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug288
Therapeutic biologic47
TCM44
Prophylactic biologic4
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

98 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢唑肟钠 · No verified English name424
2Potassium Chloride Oral Solution3311
3Levofloxacin Injection321
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets3212
5Levofloxacin and Sodium Chloride Injection3114
6Pregabalin Extended release Tablets3113
7Acetylcysteine Injection2253
8Diprophylline Injection227
9吸入用丙酸倍氯米松混悬液 · No verified English name223
10Levodopa and Benserazide Hydrochloride Tablets222

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novartis Pharma AG830
2Zhengzhou Rui Long Pharmaceutical Co., Ltd. romanized650
3AstraZeneca AB640
4Sanofi-Aventis Recherche & Developpement610
5ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.521
6Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized510
7ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.433
8Novo Nordisk A/S420
9Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized420
10Boehringer Ingelheim International GmbH410

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

148 this week

AcceptedDrugApplicants
2024/01/13Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400206 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2400205 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2400204 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 Ferrous Succinate TabletsCYHS2400200 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/01/13Generic · Class 3 阿奇霉素颗粒 · No verified English nameCYHS2400199 Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 Potassium Chloride Oral SolutionCYHS2400197 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/01/13Generic · Class 3 Bifonazole SolutionCYHS2400194 Fu Yuan Pharma Co., Ltd. romanized
2024/01/13Generic · Class 3 Pregabalin Extended release TabletsCYHL2400019 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/01/13Generic · Class 3 Pregabalin Extended release TabletsCYHL2400018 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/01/13Generic · Class 3 Pregabalin Extended release TabletsCYHL2400017 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/01/13New drug · Class 1.1 香术平胃散 · No verified English nameCXZL2400003 Jiangsu Zhong Yong Hong Rui Pharmaceutical Co., Ltd. romanized
2024/01/13New drug · Class 1 HB0046注射液 · No verified English nameCXSL2400029 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/01/13New drug · Class 1 JX2105胶囊 · No verified English nameCXHL2400070 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/13New drug · Class 1 JX2105胶囊 · No verified English nameCXHL2400069 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/13New drug · Class 1 JX2105胶囊 · No verified English nameCXHL2400068 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/13New drug · Class 1 JX2105胶囊 · No verified English nameCXHL2400067 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2024/01/13New drug · Class 2.2 SL-0013片 · No verified English nameCXHL2400066 Shanghai Ze Zheng Biopharmaceuticals Co., Ltd. romanized; Shandong University romanized
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400018 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400017 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400016 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400015 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400014 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400013 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Generic · Class 3 Potassium Chloride GranulesCYHS2400193 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/12Generic · Class 3 Potassium Chloride GranulesCYHS2400192 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/01/12Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2400188 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2024/01/12Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400187 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/01/12Generic · Class 3 Epinephrine InjectionCYHS2400186 Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/01/12Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2400185 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2024/01/12Generic · Class 3 Haloperidol TabletsCYHS2400177 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.

118 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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