YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 407 drug applications between 10 July 2023 and 16 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 55 drug names.

2023/07/10 – 2023/07/16

Period
2023/07/10 to 2023/07/16, 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
407
Drugs with new generic filings (by drug name, de-duplicated)
55
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

407filings, 77 of them generic

By application type

Application typeFilings
Supplement219
Generic77
New drug54
Import26
Import re-registration23
Unspecified8

By drug type

Drug typeFilings
Chemical drug305
Therapeutic biologic49
TCM44
Prophylactic biologic8
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

55 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vortioxetine Hydrobromide Tablets4210
2注射用头孢唑肟钠 · No verified English name424
3Potassium Chloride Oral Solution3211
4Sodium Hyaluronate Eye Drops3230
5Lidocaine and Prilocaine Cream2224
6Acetylcysteine Granules214
7Ethyl Iosapentate Capsules2127
8Carbazochrome Sodium Sulfonate Injection211
9复方奥美拉唑干混悬剂 · No verified English name210
10Oxcarbazepine Tablets214

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32230
2Hainan Brilliant Pharmaceutical Co., Ltd.1530
3AstraZeneca AB830
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
5Boehringer Ingelheim International GmbH640
6Upjohn Manufacturing Ireland Unlimited Company610
7Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
8Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized532
9Bei Da Pharmaceuticals Co., Ltd. romanized523
10Intas Pharmaceuticals. Ltd.510

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

99 this week

AcceptedDrugApplicants
2023/07/15New drug · Class 2.1 泰它西普注射液 · No verified English nameCXSL2300485 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/07/15New drug · Class 1 MC-1-50细胞制剂 · No verified English nameCXSL2300484 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2023/07/15New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300482 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/07/15New drug · Class 1 LQ3片 · No verified English nameCXHL2300785 Sichuan Yi A Suo Pharmaceuticals Technology Co., Ltd. romanized
2023/07/15New drug · Class 1 LQ3片 · No verified English nameCXHL2300784 Sichuan Yi A Suo Pharmaceuticals Technology Co., Ltd. romanized
2023/07/15New drug · Class 1 LQ3片 · No verified English nameCXHL2300783 Sichuan Yi A Suo Pharmaceuticals Technology Co., Ltd. romanized
2023/07/14Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2300058 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/07/14Import · Class 1 IMG-020注射液 · No verified English nameJXSL2300129 INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300161 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300160 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Import · Class 1 RO7435846片 · No verified English nameJXHL2300159 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/07/14Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2301904 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2301902 Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2301901 Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized
2023/07/14Generic · Class 3 Desonide CreamCYHS2301899 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/07/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301894 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/14New drug · Class 1 注射用ASKG315 · No verified English nameCXSL2300481 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2023/07/14New drug · Class 1.2 自复制RNA带状疱疹疫苗(JCXH-105注射液) · No verified English nameCXSL2300480 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2023/07/14New drug · Class 1 重组人源抗狂犬病病毒单克隆抗体注射液 · No verified English nameCXSL2300479 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/14New drug · Class 1 QR059349片 · No verified English nameCXHL2300782 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/07/14New drug · Class 1 QR059349片 · No verified English nameCXHL2300781 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/07/14New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2300780 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2023/07/14New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2300779 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2023/07/13Import · Class 3.1 注射用泰朗妥昔单抗 · No verified English nameJXSS2300057 ADC Therapeutics SA; BSP Pharmaceuticals S.p.A.; Overland Pharmaceuticals (Shanghai) Co. Ltd.
2023/07/13Import · Class 1 Lu AF82422 注射液 · No verified English nameJXSL2300128 H. Lundbeck A/S
2023/07/13Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2301892 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301889 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301888 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Famotidine InjectionCYHS2301883 Yunnan Xian Shi Pharma Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Sodium Nitroprusside InjectionCYHS2301878 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized

69 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.