YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 431 drug applications between 5 August 2026 and 11 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.

2026/08/05 – 2026/08/11

Period
2026/08/05 to 2026/08/11, 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
431
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
214

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

431filings, 75 of them generic

By application type

Application typeFilings
Supplement251
Generic75
New drug73
Import22
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug192
TCM161
Therapeutic biologic73
Prophylactic biologic4
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

56 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
3Ambroxol Hydrochloride Solution For Inhalation3110
4Brexpiprazole Orally Disintegrating Tablets3110
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 Tablets2243
7Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)2217
8Cyclophosphamide for Injection213
9盐酸西替利嗪滴剂 · No verified English name218
10Mirogabalin Besilate Tablets2161

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

259 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized750
2Topfond Pharmaceutical Co., Ltd.660
3Hubei Dong Xin Pharma Co., Ltd. romanized660
4Bayer Inc.610
5Gilead Sciences Inc.610
6Janssen Research & Development LLC530
7GlaxoSmithKline Trading Services Limited520
8Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized510
9Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized440
10Suzhou Sheng Di Ya Biopharmaceuticals 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

116 this week

AcceptedDrugApplicants
2026/08/11Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600192 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/08/11Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600191 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/08/11Import · Class 2.4 AZD9833片 · No verified English nameJXHL2600334 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2026/08/11Generic · Class 3 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2601968 Anhui Mao Kang Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2026/08/11Generic · Class 3 Tofacitinib Citrate Oral SolutionCYHS2601966 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2026/08/11Generic · Class 3 Irbesartan and Amlodipine TabletsCYHS2601964 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2026/08/11Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2601963 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2026/08/11Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2601962 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2026/08/11Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2601961 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2026/08/11New drug · Class 1 KL002注射液 · No verified English nameCXSL2600854 Kang Lin Bio Technology (Hangzhou) Co., Ltd. romanized
2026/08/11New drug · Class 3.3 注射用TKB02 · No verified English nameCXSL2600853 Anhui Tai En Kang Bio Gong Cheng Co., Ltd. romanized
2026/08/11New drug · Class 1 重组柯萨奇病毒B3注射液 · No verified English nameCXSL2600852 Wuhan Bo Wei De Bio Technology Co., Ltd. romanized
2026/08/11New drug · Class 1 盐酸阿氟色替片 · No verified English nameCXHS2600117 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/08/11New drug · Class 1 盐酸阿氟色替片 · No verified English nameCXHS2600116 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
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

86 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.