YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 461 drug applications between 28 July 2026 and 3 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 87, covering 61 drug names.

2026/07/28 – 2026/08/03

Period
2026/07/28 to 2026/08/03, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
461
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
175

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

461filings, 87 of them generic

By application type

Application typeFilings
Supplement241
Generic87
New drug78
Import32
Unspecified15
Import re-registration8

By drug type

Drug typeFilings
Chemical drug243
TCM143
Therapeutic biologic71
Biologic4

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name4226
2Dapagliflozin Tablets4284
3Ixazomib Citrate Capsules317
4注射用泼尼松龙琥珀酸钠 · No verified English name313
5Oseltamivir Phosphate Capsules3139
6盐酸氮?斯汀鼻喷雾剂 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.227
7Ipratropium Bromide Inhalation Solution212
8Dotinurad Tablets2155
9Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
10注射用托伐普坦磷酸钠 · No verified English name2115

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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Inc.1370
2Eli Lilly and Company720
3Liaoning Min Kang Pharmaceutical Co., Ltd. romanized620
4Name not romanized610
5Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized550
6AstraZeneca AB540
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD523
8Novo Nordisk A/S510
9Takeda Development Center Americas Inc.510
10Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized440

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

132 this week

AcceptedDrugApplicants
2026/08/03Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2600185 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/03Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2600184 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/03Import · Class 1 ABBV-382注射液 · No verified English nameJXSL2600183 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/03Import · Class 1 MAR002 · No verified English nameJXSL2600182 Marea Therapeutics Inc.; Beijing MEDPACE Ltd.
2026/08/03Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600181 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/03Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600180 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/08/03Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600313 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/03Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600312 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/03Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600311 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/03Import · Class 1 Eloralintide注射液 · No verified English nameJXHL2600310 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/03Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2601877 Nanjing Hai Jing Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2601876 Nanjing Hai Jing Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601868 Bai Yun Shan Tang Yin Dong Tai Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601866 Bai Yun Shan Tang Yin Dong Tai Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601863 Guangdong Long Fu Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2601857 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2601855 Jilin Hua Kang Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2601854 Jilin Hua Kang Pharma Co., Ltd. romanized
2026/08/03Generic · Class 3 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English nameCYHS2601853 Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/08/03New drug · Class 1.1 1301-07颗粒 · No verified English nameCXZL2600069 Zhongguo Yao Ke University romanized
2026/08/03New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600811 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/03New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2600810 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/03New drug · Class 1 ABBV-701注射液 · No verified English nameCXSL2600809 Ai Bo Wei Pharmaceuticals Trading (Shanghai) Co., Ltd. romanized
2026/08/03New drug · Class 1 QLS2401注射液 · No verified English nameCXSL2600808 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/08/03New drug · Class 1 艾托莫德片 · No verified English nameCXHL2600952 Jian Kuan (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/31Generic · Class 3 硫酸阿托品滴眼液 · No verified English nameCYHS2601848 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2026/07/31New drug · Class 1.1 复方野菊花颗粒 · No verified English nameCXZL2600068 Zhejiang Zhong Pharmaceuticals University romanized
2026/07/31New drug · Class 1.1 藿连消滞颗粒 · No verified English nameCXZL2600067 He Guang Zhong Yao Technology (Tianjin) Co., Ltd. romanized
2026/07/31New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600807 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用3SN001 · No verified English nameCXSL2600806 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized

102 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.