YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 243 drug applications between 29 June 2021 and 5 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 27 drug names.

2021/06/29 – 2021/07/05

Period
2021/06/29 to 2021/07/05, 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
243
Drugs with new generic filings (by drug name, de-duplicated)
27
Accepted this week, now under review
0

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

243filings, 37 of them generic

By application type

Application typeFilings
Supplement132
New drug39
Generic37
Import25
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug163
Therapeutic biologic41
TCM32
Prophylactic biologic7

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets7323
2Clindamycin Injection214
3Lidocaine Hydrochloride Injection216
4Dabigatran Etexilate Capsules212
5Febuxostat Tablets2112
6ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name110
7Risperidone Oral Solution116
8Compound Ipratropium Bromide Solution For Inhalation114
9噻托溴铵吸入粉雾剂 · No verified English name112
10地氯雷他定口服溶液 · No verified English name1126

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

136 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Liang Ji Pharma Co., Ltd. romanized14140
2Jiangsu Guang Cheng Pharma Co., Ltd. romanized660
3Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized660
4Zhejiang Hui Di Sen Pharma Co., Ltd. romanized620
5Roche Pharma (Schweiz) Ltd.610
6AstraZeneca AB530
7Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized440
8Merck Sharp & Dohme Corp.420
9Novo Nordisk A/S420
10GlaxoSmithKline Biologicals SA410

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

74 this week

AcceptedDrugApplicants
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101116 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101115 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101114 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101113 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101112 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101111 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101110 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 Belzutifan片 · No verified English nameJXHL2101109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2021/07/05Generic · Class 3 Mesalamine extended release capsulesCYHS2101385 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2021/07/05Generic · Class 3 Pregabalin Extended release TabletsCYHL2101017 Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized
2021/07/05New drug · Class 1.1 脑脉通颗粒 · No verified English nameCXZL2101016 Guangdong Yao Ke University romanized
2021/07/05New drug · Class 1 普特利单抗注射液 · No verified English nameCXSS2101008 Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2021/07/05New drug · Class 1 注射用QLF31907 · No verified English nameCXSL2101171 Qilu Pharmaceutical Co., Ltd.
2021/07/05New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2101170 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2021/07/05New drug · Class 1 注射用BJ-005 · No verified English nameCXSL2101168 Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2021/07/05New drug · Class 1 HS-10241片 · No verified English nameCXHL2101262 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/05New drug · Class 1 HS-10241片 · No verified English nameCXHL2101261 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/05New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHL2101260 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/05New drug · Class 2.4 Lenvatinib Mesilate CapsulesCXHL2101259 Xian Sheng Pharma Co., Ltd. romanized
2021/07/05New drug · Class 1 JYP0061片 · No verified English nameCXHL2101253 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/07/05New drug · Class 1 JYP0061片 · No verified English nameCXHL2101252 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/07/05New drug · Class 1 JYP0061片 · No verified English nameCXHL2101251 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/07/02Import · Class 3.1 莫格利珠单抗注射液 · No verified English nameJXSS2101015 Kyowa Kirin Co. Ltd.; Toyobo Company Limited Otsu Pharmaceutical Plant
2021/07/02Import · Class 2.2 DS-8201a · No verified English nameJXSL2101064 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/07/02Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101063 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/02Import · Class 1 RO7247669注射液 · No verified English nameJXSL2101059 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd
2021/07/02Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2101380 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2021/07/02Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2101379 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2021/07/02New drug · Class 1.2 广金钱草总黄酮胶囊 · No verified English nameCXZS2101003 Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized
2021/07/02New drug · Class 1 EP-9001A注射液 · No verified English nameCXSL2101166 Chengdu You Luo Bio Technology Co., Ltd. romanized

44 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.