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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 401 drug applications between 3 December 2024 and 9 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 131, covering 91 drug names.

2024/12/03 – 2024/12/09

Period
2024/12/03 to 2024/12/09, 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
401
Drugs with new generic filings (by drug name, de-duplicated)
91
Accepted this week, now under review
9

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

401filings, 131 of them generic

By application type

Application typeFilings
Supplement178
Generic131
New drug63
Import16
Unspecified8
Import re-registration3
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug261
TCM66
Therapeutic biologic64
Biologic7
Prophylactic biologic2
In vitro diagnostic reagent1

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

91 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution5134
2Vonoprazan Fumarate Tablets4260
3Ambroxol Hydrochloride Oral Solution4146
4Oxcarbazepine Extended-release Tablets310
5Procaterol Hydrochloride Granules312
6Levocarnitine Oral Solution229
7Polymyxin B sulfate for Injection226
8Isavuconazonium Sulfate for Injection2215
9Sodium Hyaluronate Eye Drops2230
10Mupirocin Ointment2230

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

245 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized11110
2Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized1020
3Shandong Xin Shi Dai Pharma Co., Ltd. romanized620
4Jiangxi Ke Lun Pharma Co., Ltd. romanized620
5Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized555
6SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED541
7Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized535
8Ren He Yi Kang Group Co., Ltd. romanized522
9Shaanxi Xing Bang Pharma Co., Ltd. romanized515
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized430

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

122 this week

AcceptedDrugApplicants
2024/12/09Generic · Class 3 Zoledronic Acid InjectionCYHS2404256 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2024/12/09Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2400250 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2024/12/09Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHL2400249 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2024/12/09New drug · Class 2.3 氟替格维吸入气雾剂 · No verified English nameCXHL2401331 Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized; Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized
2024/12/07Import · Class 2.3 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400110 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2024/12/07Import · Class 2.3 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400109 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2024/12/07Import · Class 2.2 注射用玛贝兰妥单抗 · No verified English nameJXSS2400108 GlaxoSmithKline Trading Services Limited; Glaxosmithkline Manufacturing S.p.A.; GlaxoSmithKline (China) Investment Co. Limited
2024/12/07Import · Class 2.2 注射用玛贝兰妥单抗 · No verified English nameJXSS2400107 GlaxoSmithKline Trading Services Limited; Glaxosmithkline Manufacturing S.p.A.; GlaxoSmithKline (China) Investment Co. Limited
2024/12/07Import · Class 2.3 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400106 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2024/12/07Import · Class 1 伊坦长效重组人生长激素注射液 · No verified English nameJXSS2400105 YI-MAB BIOTECH HONG KONG LIMITED; PATHEON ITALIA S.P.A.; TJ Biopharma (Hangzhou) Co. Ltd.
2024/12/07Import · Class 1 注射用MK-6070 · No verified English nameJXSL2400234 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/12/07Import · Class 1 注射用MK-2400 · No verified English nameJXSL2400233 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/12/07Generic · Class 3 Progesterone InjectionCYHS2404246 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/07Generic · Class 3 Baclofen Oral SolutionCYHS2404238 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2024/12/07New drug · Class 1 注射用BL-M07D1 · No verified English nameCXSL2400836 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/12/07New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400835 Name not romanized; Name not romanized
2024/12/07New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2400834 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/12/07New drug · Class 1 IBI3002 · No verified English nameCXSL2400833 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/12/07New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401330 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/12/07New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401329 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/12/07New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401328 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/12/07New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401327 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/12/06Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404234 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/06Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404233 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/12/06Generic · Class 3 Progesterone InjectionCYHS2404227 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized
2024/12/06Generic · Class 3 Sodium Bicarbonate InjectionCYHS2404225 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Sodium Bicarbonate InjectionCYHS2404224 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Terbutaline Sulfate InjectionCYHS2404218 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized
2024/12/06Generic · Class 3 Indocyaninegreen for InjectionCYHS2404217 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/12/06Generic · Class 3 Terbutaline Sulfate InjectionCYHS2404216 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized

92 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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