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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 487 drug applications between 6 January 2023 and 12 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 68 drug names.

2023/01/06 – 2023/01/12

Period
2023/01/06 to 2023/01/12, 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
487
Drugs with new generic filings (by drug name, de-duplicated)
68
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

487filings, 93 of them generic

By application type

Application typeFilings
Supplement242
Generic93
New drug85
Import42
Import re-registration15
Unspecified10

By drug type

Drug typeFilings
Chemical drug339
Therapeutic biologic80
TCM62
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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops4116
2Sodium Hyaluronate Eye Drops4130
3Dopamine Hydrochloride Injection313
4Lidocaine and Prilocaine Cream2224
5Ritonavir Tablets220
6Dobutamine Hydrochloride Injection223
7Fluvoxamine Maleate Tablets220
8Avatrombopag Maleate Tablets220
9Lactulose Oral Solution2134
10布比卡因脂质体注射液 · No verified English name217

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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Luo Bang Pharma Co., Ltd. romanized25190
2Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized12120
3Zhengzhou Shi Bao Long Pharma Co., Ltd. romanized880
4Eli Lilly Nederland B.V.840
5Suzhou Hong Sen Pharma Co., Ltd. romanized828
6Pfizer Europe MA EEIG740
7Novo Nordisk A/S730
8Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized630
9Hangzhou An Dao Pharma Co., Ltd. romanized610
10Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized550

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

158 this week

AcceptedDrugApplicants
2023/01/12Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300010 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/01/12Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300009 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/01/12Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300008 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/01/12Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSS2300007 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2023/01/12Import · Class 1 佩索利单抗注射液 · No verified English nameJXSL2300022 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/01/12Import · Class 1 佩索利单抗注射液 · No verified English nameJXSL2300021 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/01/12Generic · Class 3 帕拉米韦氯化钠注射液 · No verified English nameCYHS2300121 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/12Generic · Class 3 Minoxidil LinimentCYHS2300120 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/01/12Generic · Class 3 Aripiprazole Oral SolutionCYHS2300119 Chang Xing Pharmaceutical Co., Ltd. romanized
2023/01/12Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2300118 Fujian Hui Tian Bio Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/01/12Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300114 CISEN PHARMACEUTICAL CO., LTD.
2023/01/12Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300113 CISEN PHARMACEUTICAL CO., LTD.
2023/01/12Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2300112 Bei Da Pharmaceuticals Co., Ltd. romanized
2023/01/12Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2300111 Bei Da Pharmaceuticals Co., Ltd. romanized
2023/01/12Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2300110 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/01/12New drug · Class 1 重组抗人IL-4Rα和IL-5单域抗体注射液 (RC1416注射液) · No verified English nameCXSL2300032 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2023/01/12New drug · Class 1 CM369注射液 · No verified English nameCXSL2300031 Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized
2023/01/12New drug · Class 1 STI-8591胶囊 · No verified English nameCXHL2300067 Zhejiang Ai Sen Pharma Co., Ltd. romanized; Hangzhou Ai Sen Pharmaceuticals Research Co., Ltd. romanized
2023/01/12New drug · Class 1 QR060127胶囊 · No verified English nameCXHL2300066 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/01/12New drug · Class 1 QR060127胶囊 · No verified English nameCXHL2300065 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/01/12New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2300064 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/01/12New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2300063 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2023/01/11Import · Class 3.1 度拉糖肽注射液 · No verified English nameJXSS2300006 Eli Lilly Nederland B.V.; Vetter Pharma-Fertigung GmbH & Co.KG; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/01/11Import · Class 3.1 度拉糖肽注射液 · No verified English nameJXSS2300005 Eli Lilly Nederland B.V.; Vetter Pharma-Fertigung GmbH & Co.KG; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/01/11Import · Class 1 PF-07901801注射液 · No verified English nameJXSL2300020 Pfizer Inc.; Pfizer Investment CO. Ltd.
2023/01/11Import · Class 1 帕萨利司片 · No verified English nameJXHL2300007 Incyte Corporation; Innovent Biologics (Suzhou) Co. Ltd
2023/01/11Import · Class 1 帕萨利司片 · No verified English nameJXHL2300006 Incyte Corporation; Innovent Biologics (Suzhou) Co. Ltd
2023/01/11Import · Class 1 注射用3D-189 · No verified English nameJXHL2300005 3D Medicines Inc.; 3D Medicines (Qingdao) Co. Limited
2023/01/11Generic · Class 3 Vincriscristine Sulfate InjectionCYHS2300105 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/01/11Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300097 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized

128 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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