YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 482 drug applications between 4 August 2026 and 10 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 76, covering 55 drug names.

2026/08/04 – 2026/08/10

Period
2026/08/04 to 2026/08/10, 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
482
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
237

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

482filings, 76 of them generic

By application type

Application typeFilings
Supplement279
New drug88
Generic76
Import29
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug210
TCM193
Therapeutic biologic76
Prophylactic biologic3

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
1Dapagliflozin Tablets4284
2替尔泊肽注射液 · No verified English name4122
3Loxoprofen Sodium Patches3230
4Ambroxol Hydrochloride Solution For Inhalation3110
5鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name316
6Upadacitinib Sustained-release Tablets2240
7Edaravone and Dexborneol Concentrated Solution for Injection2234
8Sivelestat Sodium for Injection225
9Cyclophosphamide for Injection213
10Nafamostat Mesilate for Injection2138

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

276 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized17160
2Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized750
3Eli Lilly and Company710
4Topfond Pharmaceutical Co., Ltd.660
5Bayer Inc.610
6Gilead Sciences Inc.610
7Li Zhu Group Li Min Pharmaceutical Factory romanized610
8GlaxoSmithKline Trading Services Limited520
9Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized510
10Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized510

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

138 this week

AcceptedDrugApplicants
2026/08/10Import · Class 1.4 PG4 · No verified English nameJXSL2600189 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/08/10Import · Class 1 Venglustat · No verified English nameJXHL2600333 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2026/08/10Import · Class 1 Venglustat · No verified English nameJXHL2600332 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd
2026/08/10Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2601951 Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2026/08/10Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601949 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2026/08/10Generic · Class 3 Probucol TabletsCYHS2601948 Zhejiang Jiang Bei Pharma Co., Ltd. romanized
2026/08/10Generic · Class 3 Sivelestat Sodium for InjectionCYHS2601944 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/08/10New drug · Class 1.2 CE-201片 · No verified English nameCXZL2600074 Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized
2026/08/10New drug · Class 1.2 CE-201片 · No verified English nameCXZL2600073 Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized
2026/08/10New drug · Class 1.2 CE-101 · No verified English nameCXZL2600072 Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized
2026/08/10New drug · Class 2.1 注射用正清风痛宁 · No verified English nameCXZL2600071 Hunan Zheng Qing Pharmaceutical Group Co., Ltd. romanized
2026/08/10New drug · Class 1 CM551注射液 · No verified English nameCXSL2600851 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/10New drug · Class 3.3 AK2401注射液 · No verified English nameCXSL2600850 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2026/08/10New drug · Class 1 ICP-B381 · No verified English nameCXSL2600849 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/08/10New drug · Class 1 BJ045注射液(皮下注射) · No verified English nameCXSL2600848 Shanghai Bao Ji Pharma Co., Ltd. romanized
2026/08/10New drug · Class 1 90Y-NRT6020注射液 · No verified English nameCXHL2600980 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2026/08/10New drug · Class 1 HRS-5346 片 · No verified English nameCXHL2600979 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/10New drug · Class 1 HRS-2189片 · No verified English nameCXHL2600978 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/10New drug · Class 1 HRS-2189片 · No verified English nameCXHL2600977 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/07Import · Class 3.1 尼塞韦单抗注射液 · No verified English nameJXSS2600072 Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd.
2026/08/07Import · Class 3.1 尼塞韦单抗注射液 · No verified English nameJXSS2600071 Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600331 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600330 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600329 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Generic · Class 3 Ferrous Succinate TabletsCYHS2601935 Anhui Zheng Yao Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/08/07Generic · Class 3 Acetaminophen InjectionCYHS2601934 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/08/07Generic · Class 3 Gatifloxacin Eye DropsCYHS2601932 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized
2026/08/07Generic · Class 3 Ropinirole Hydrochloride TabletsCYHS2601930 Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized
2026/08/07New drug · Class 3.1 当归六黄汤颗粒 · No verified English nameCXZS2600045 Shen Wei Pharma Group Co., Ltd. romanized
2026/08/07New drug · Class 3.1 厚朴温中汤颗粒 · No verified English nameCXZS2600044 Shen Wei Pharma Group Co., Ltd. romanized

108 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.