YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 27 June 2024 and 3 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.

2024/06/27 – 2024/07/03

Period
2024/06/27 to 2024/07/03, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
5

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

329filings, 90 of them generic

By application type

Application typeFilings
Supplement177
Generic90
New drug34
Import13
Import re-registration12
Unspecified3

By drug type

Drug typeFilings
Chemical drug235
TCM55
Therapeutic biologic33
Prophylactic biologic6

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection4313
2Calcium Folinate Injection224
3Epalrestat Tablets221
4Ibuprofen Suspension2214
5Penehyclidine Hydrochloride Injection222
6盐酸阿莫罗芬搽剂 · No verified English name2215
7维生素B6注射液 · No verified English name2210
8Ipratropium Bromide Inhalation Solution212
9Procaterol Hydrochloride Solution for Inhalation212
10Diquafosol Sodium Eye Drops215

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

198 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Luo Yang Hao Long Pharma Co., Ltd. romanized1780
2Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized10100
3AstraZeneca AB630
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
5Ha Yao Group Pharmaceutical Factory romanized530
6Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized440
7Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized430
8Shanxi Hua Kang Pharma Co., Ltd. romanized430
9Ren He Yi Kang Group Co., Ltd. romanized422
10Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized410

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

83 this week

AcceptedDrugApplicants
2024/07/03Import · Class 2.1; 2.2 古塞奇尤单抗注射液(静脉输注) · No verified English nameJXSS2400054 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/07/03Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2400053 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/07/03Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2400052 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/07/03Import · Class 1 VGX-3100 · No verified English nameJXSL2400119 Inovio Pharmaceuticals Inc.; Beijing Apollo Saturn Biological Technology Limited
2024/07/03Import · Class 2.4 注射用68Ga-PSMA-11 · No verified English nameJXHL2400154 Telix Pharmaceuticals (US) Inc.; Grand Pharmaceutical (China) Co. Ltd.
2024/07/03Generic · Class 3 Tofacitinib Citrate Oral SolutionCYHS2402004 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/07/03Generic · Class 3 Tofacitinib Citrate Oral SolutionCYHS2402003 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/07/03Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2402002 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2024/07/03Generic · Class 3 Epalrestat TabletsCYHS2402001 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2024/07/03Generic · Class 3 Thiotepa for InjectionCYHS2402000 Heilongjiang Fu He Pharmaceutical Group Co., Ltd. romanized
2024/07/03Generic · Class 3 Potassium Phosphates InjectionCYHS2401998 Yi Yao Tong (Hebei) Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/07/03Generic · Class 3 Epalrestat TabletsCYHS2401994 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2024/07/03Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2401989 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/07/03New drug · Class 1 Obexelimab注射液 · No verified English nameCXSL2400423 Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized
2024/07/03New drug · Class 1 LTC004 · No verified English nameCXSL2400422 Beijing Zhi Dao Bio Technology Co., Ltd. romanized
2024/07/02Import · Class 1 AMG 451 · No verified English nameJXSL2400118 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/07/02Import · Class 1 AZD0780薄膜衣片 · No verified English nameJXHL2400151 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/07/02Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2401981 Shanghai Feng Lin Bio Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Obeticholic Acid TabletsCYHS2401974 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/07/02Generic · Class 3 Obeticholic Acid TabletsCYHS2401973 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/07/02Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401972 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/07/02Generic · Class 3 Vitamin K1 InjectionCYHS2401970 Hainan Hua Yi Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Potassium Chloride GranulesCYHS2401968 Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 Potassium Chloride GranulesCYHS2401967 Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized
2024/07/02Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2401966 Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/07/02Generic · Class 3 Sulpiride InjectionCYHS2401964 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/02Generic · Class 3 Allopurinol TabletsCYHS2401963 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2024/07/02New drug · Class 1.1 艾康片 · No verified English nameCXZL2400037 An Hua Heng Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2024/07/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400421 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/07/02New drug · Class 1 KYS202004A注射液 · No verified English nameCXSL2400420 Jiangsu Kang Yuan Pharma Co., Ltd. romanized

53 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.