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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 486 drug applications between 21 September 2024 and 27 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 142, covering 100 drug names.

2024/09/21 – 2024/09/27

Period
2024/09/21 to 2024/09/27, 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
486
Drugs with new generic filings (by drug name, de-duplicated)
100
Accepted this week, now under review
13

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

486filings, 142 of them generic

By application type

Application typeFilings
Supplement184
Generic142
New drug81
Import36
Unspecified32
Import re-registration10
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug302
Therapeutic biologic77
TCM73
Biologic26
Prophylactic biologic8

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

100 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets6231
2Fentanyl Citrate Buccal Tablets610
3Cefoperazone Sodium and Sulbactam Sodium for Injection6114
4Dapagliflozin Tablets3284
5Carbamazepine Sustained-Release Tablets(II)310
6Brexpiprazole Orally Disintegrating Tablets3110
7Amoxicillin Sodium and Sulbactam Sodium for Injection317
8Procaterol Hydrochloride Granules312
9Ethyl Iosapentate Capsules2227
10Tadalafil Tablets2223

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

286 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1560
2Amgen Inc.920
3Yi Chang Ren Fu Pharma Co., Ltd. romanized929
4Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized730
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Zhejiang Wo Wu Bio Technology Co., Ltd. romanized710
7Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized660
8AstraZeneca AB630
9Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized630
10Janssen-Cilag International NV620

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

176 this week

AcceptedDrugApplicants
2024/09/27Import · Class 1 MEDI5752 · No verified English nameJXSL2400185 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/27Import · Class 1 AZD2936 · No verified English nameJXSL2400184 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/27Import · Class 2.2 DS-8201a · No verified English nameJXSL2400183 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2024/09/27Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400238 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2024/09/27Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2403272 Xian Jing Xi Shuang He Pharma Co., Ltd. romanized
2024/09/27Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(I) · No verified English nameCYHS2403271 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2024/09/27Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2403265 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/09/27Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2403264 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/09/27Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2403263 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/09/27New drug · Class 1 KJ015注射液(皮下注射) · No verified English nameCXSL2400672 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/09/27New drug · Class 3.4 治疗用重组卡介苗 · No verified English nameCXSL2400671 Chengdu An Yong Ding Ye Bio Technology Co., Ltd. romanized
2024/09/27New drug · Class 2.4 重组人透明质酸酶注射液 · No verified English nameCXSL2400670 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/09/27New drug · Class 2.4 重组人透明质酸酶注射液 · No verified English nameCXSL2400669 Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/09/27New drug · Class 2.2 SBK010口服溶液 · No verified English nameCXHS2400099 Jin Zhou Ao Hong Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2024/09/27New drug · Class 1 伊匹乌肽滴鼻剂 · No verified English nameCXHL2401019 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
2024/09/27New drug · Class 1 HRS-4357注射液 · No verified English nameCXHL2401018 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/27New drug · Class 2.2 注射用JMX-2006 · No verified English nameCXHL2401017 Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized
2024/09/27New drug · Class 2.2; 2.4 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2401016 Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized
2024/09/27New drug · Class 2.2; 2.4 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2401015 Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized
2024/09/27New drug · Class 1 TBA片 · No verified English nameCXHL2401014 Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/09/27New drug · Class 1 TBA片 · No verified English nameCXHL2401013 Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/09/27New drug · Class 1 TBA片 · No verified English nameCXHL2401012 Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/09/26Import · Class 1 PF-08046047 · No verified English nameJXSL2400182 Seagen Inc.; Pfizer Investment CO. Ltd.
2024/09/26Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400181 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/26Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400180 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400237 Eisai Co. Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400236 Eisai Co. Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400235 Eisai Co. Ltd.
2024/09/26Generic · Class 3 Aceclofenac TabletsCYHS2403261 Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Minodronic acid TabletsCYHS2403258 Shandong Xin Shi Dai Pharma Co., Ltd. romanized

146 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.

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