YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 262 drug applications between 29 May 2025 and 4 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 52 drug names.

2025/05/29 – 2025/06/04

Period
2025/05/29 to 2025/06/04, 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
262
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
39

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

262filings, 74 of them generic

By application type

Application typeFilings
Supplement124
Generic74
New drug45
Import8
Unspecified5
Import re-registration5
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug161
TCM58
Therapeutic biologic37
Prophylactic biologic4
Biologic2

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection7753
2Dapagliflozin Tablets4284
3Brexpiprazole Tablets3131
4维生素B6注射液 · No verified English name2210
5Tadalafil Tablets2123
6利伐沙班颗粒 · No verified English name212
7复方氨基酸注射液(20AA-Ⅱ) · No verified English name210
8Hydrocortisone Sodium Succinate for Injection2116
9Loxoprofen Sodium Patches2130
10Safinamide Methansulfonate Tablets2120

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

171 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized950
2Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized870
3Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized545
4Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized440
5Jiangxi Ke Rui Pharma Co., Ltd. romanized430
6Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized432
7CISEN PHARMACEUTICAL CO., LTD.420
8Shaanxi Pan Long Pharma Group Co., Ltd. romanized420
9Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized410
10Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized330

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

76 this week

AcceptedDrugApplicants
2025/06/04Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500124 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/06/04Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500123 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/06/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501975 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501974 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2501972 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2501966 Fujian Bo Yue Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/06/04Generic · Class 3 Minoxidil LinimentCYHS2501965 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2025/06/04Generic · Class 3 Lidocaine and Prilocaine Periodontal GelCYHL2500103 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/06/04New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2500024 Shen Wei Pharma Group Co., Ltd. romanized
2025/06/04New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSS2500058 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/06/04New drug · Class 3.3 SAL023注射液 · No verified English nameCXSL2500445 Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/06/04New drug · Class 1 注射用DXC018 · No verified English nameCXSL2500444 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2025/06/04New drug · Class 2.4 Fruquintinib CapsulesCXHS2500060 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd., He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/06/04New drug · Class 2.4 Fruquintinib CapsulesCXHS2500059 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd., He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/06/04New drug · Class 1 D-2570片 · No verified English nameCXHL2500529 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2025/06/04New drug · Class 2.2 ZK062 · No verified English nameCXHL2500528 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/06/03Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2501973 Zhejiang Hai Chang Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/05/31Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2501949 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/05/31Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2501948 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/05/31Generic · Class 3 Salbutamol Sulfate injectionCYHS2501947 Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/05/31Generic · Class 3 Flurbiprofen PatchesCYHS2501944 Hunan Jiudian Pharmaceutical Co., Ltd
2025/05/31Generic · Class 3 Tobramycin Sulfate InjectionCYHS2501943 Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2501942 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 Terbutaline Sulfate InjectionCYHL2500102 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 Dapsone GelCYHL2500101 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/05/31New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2500023 Rui Yang Pharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 注射用STSP-0601 · No verified English nameCXSS2500057 Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized; Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 3.2 ACYW???群脑膜炎球菌多糖结合疫苗 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CXSS2500056 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 SM2275注射液 · No verified English nameCXSL2500443 Zhuhai Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/31New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500442 Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized

46 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.