YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 502 drug applications between 24 December 2024 and 30 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 171, covering 120 drug names.

2024/12/24 – 2024/12/30

Period
2024/12/24 to 2024/12/30, 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
502
Drugs with new generic filings (by drug name, de-duplicated)
120
Accepted this week, now under review
12

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

502filings, 171 of them generic

By application type

Application typeFilings
Supplement182
Generic171
New drug104
Import25
Unspecified14
Import re-registration6

By drug type

Drug typeFilings
Chemical drug368
TCM73
Therapeutic biologic60
Biologic1

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

120 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution6334
2Safinamide Methansulfonate Tablets5320
3Vonoprazan Fumarate Tablets4260
4Roxadustat Capsules4217
5Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3323
6Cimetidine Injection335
7Bumetanide Injection3213
8甲氧氯普胺片 · No verified English name323
9Minoxidil Liniment3252
10Lidocaine and Prilocaine Cream3124

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

309 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Qidu Pharmaceutical Co., Ltd.941
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized880
3AstraZeneca AB850
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.753
5Nei Menggu Da Tang Pharma Co., Ltd. romanized660
6Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized660
7Bracco Imaging S.P.A.610
8Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized610
9Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized610
10Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized531

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

209 this week

AcceptedDrugApplicants
2024/12/30Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400258 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/12/30Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400257 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/12/30Import · Class 1 Rilzabrutinib片 · No verified English nameJXHS2400121 Genzyme Corporation; Sanofi S.r.l; Sanofi (China) Investment Co. Ltd.
2024/12/30Generic · Class 3 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2404618 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/12/28Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2400256 Seagen Inc.; Pfizer Investment CO. Ltd.
2024/12/28Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2400119 AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V.
2024/12/28Generic · Class 3 Atropine Sulfate InjectionCYHS2404615 Yan Tai Wan Run Pharma Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2404614 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/12/28Generic · Class 3 盐酸多沙普仑注射液 · No verified English nameCYHS2404612 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 盐酸多沙普仑注射液 · No verified English nameCYHS2404611 Hubei Jian Cheng Bo Tai Pharmaceuticals Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 Clonazepam InjectionCYHS2404609 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2024/12/28Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2404607 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/12/28Generic · Class 3 Cimetidine InjectionCYHS2404606 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/12/28Generic · Class 3 Cimetidine InjectionCYHS2404605 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/12/28Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2404604 Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2024/12/28Generic · Class 3 Trimebutine Maleate TabletsCYHS2404603 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/28Generic · Class 3 Trimebutine Maleate TabletsCYHS2404602 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/12/28Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2404600 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2404599 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2404598 Shandong Qidu Pharmaceutical Co., Ltd.
2024/12/28Generic · Class 3 Aminophylline InjectionCYHS2404595 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2024/12/28Generic · Class 3 Aminophylline InjectionCYHS2404594 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2024/12/28Generic · Class 3 Lidocaine Hydrochloride Ophthalmic GelCYHL2400281 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/12/28Generic · Class 3 Rupatadine Fumarate Oral SolutionCYHL2400280 Guangzhou Shi Tong Hui Pharma Co., Ltd. romanized
2024/12/28Generic · Class 3 Minocycline Hydrochloride For InjectionCYHL2400279 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2024/12/28New drug · Class 3.1 半夏白术天麻汤颗粒 · No verified English nameCXZS2400040 Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized
2024/12/28New drug · Class 1 XP-001-V2 · No verified English nameCXSL2400922 Shanghai Xin Pu Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/28New drug · Class 1 注射用MHB036C · No verified English nameCXSL2400921 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/12/28New drug · Class 1 注射用MHB039A · No verified English nameCXSL2400920 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/12/28New drug · Class 1 CD-001注射液 · No verified English nameCXSL2400919 Cheng Dian (Suzhou) Biopharmaceuticals Co., Ltd. romanized

179 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.