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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 258 drug applications between 16 March 2022 and 22 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 19 drug names.

2022/03/16 – 2022/03/22

Period
2022/03/16 to 2022/03/22, 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
258
Drugs with new generic filings (by drug name, de-duplicated)
19
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

258filings, 25 of them generic

By application type

Application typeFilings
Supplement185
Generic25
New drug22
Import15
Unspecified11

By drug type

Drug typeFilings
Chemical drug165
Therapeutic biologic52
TCM26
Prophylactic biologic9
Biologic6

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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment2252
2Sodium Valproate Concentrated Solution for Injection210
3Pregabalin Capsules2112
4Dapoxetine Hydrochloride Tablets2120
5Exenatide Injection210
6Calcium Gluconate Injection215
7二硫化硒洗剂 · No verified English name1114
8Lidocaine and Prilocaine Cream1124
9布南色林片 · No verified English name110
10Peramivir Injection117

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

132 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized17150
2Jilin Sheng Dou Bang Pharma Co., Ltd. romanized1420
3Zhejiang Dou Bang Pharma Co., Ltd. romanized1220
4Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized980
5Novo Nordisk A/S830
6Kyowa Kirin Co. Ltd.610
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD510
8Janssen Research & Development LLC440
9Beijing Rui Ye Pharmaceutical Co., Ltd. romanized420
10Celgene Corporation410

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

48 this week

AcceptedDrugApplicants
2022/03/22Import · Class 1.1 九价肠外致病性大肠埃希菌疫苗 · No verified English nameJXSL2200037 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/03/22Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2200036 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2022/03/22Import · Class 2.3 Guselkumab/Golimumab(JNJ-78934804)注射液 · No verified English nameJXSL2200035 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/03/22Import · Class 2.2 戈利木单抗注射液 · No verified English nameJXSL2200034 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/03/22Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2200033 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/03/22Import · Class 2.4 赛沃替尼片 · No verified English nameJXHL2200064 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/22Import · Class 2.4 赛沃替尼片 · No verified English nameJXHL2200063 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/22Import · Class 2.4 赛沃替尼片 · No verified English nameJXHL2200062 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/22Generic · Class 3 Peramivir InjectionCYHS2200471 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2022/03/22Generic · Class 3 Calcium Gluconate InjectionCYHS2200466 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/03/22Generic · Class 3 Calcium Gluconate InjectionCYHS2200465 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/03/22New drug · Class 3.4 注射用罗普司亭 · No verified English nameCXSS2200030 Qilu Pharmaceutical Co., Ltd.
2022/03/22New drug · Class 3.4 注射用罗普司亭 · No verified English nameCXSS2200029 Qilu Pharmaceutical Co., Ltd.
2022/03/22New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2200139 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2022/03/22New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2200138 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2022/03/22New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2200137 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2022/03/22New drug · Class 1 PMG1015注射液 · No verified English nameCXSL2200136 Pu Mu (Beijing) Bio Technology Co., Ltd. romanized
2022/03/22New drug · Class 1 TRN-157雾化吸入剂 · No verified English nameCXHL2200172 Shandong Lukang Pharmaceutical Co.,Ltd.
2022/03/21Import · Class 2.2 注射用Trastuzumab Deruxtecan · No verified English nameJXSS2200011 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2022/03/21Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200032 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/03/21Generic · Class 3 Minoxidil LinimentCYHS2200470 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/03/21Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2200464 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2022/03/21Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2200463 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized
2022/03/21Generic · Class 3 Ramelteon TabletsCYHL2200025 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2022/03/21New drug · Class 1 皮炎诊断贴剂01贴 · No verified English nameCXSL2200135 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2022/03/21New drug · Class 1 GB261注射液 · No verified English nameCXSL2200133 Jia He Bio Pharma Co., Ltd. romanized
2022/03/21New drug · Class 1 CM313注射液 · No verified English nameCXSL2200131 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2022/03/21New drug · Class 1 AZD4547片 · No verified English nameCXHL2200171 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/21New drug · Class 1 AZD4547片 · No verified English nameCXHL2200170 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/21New drug · Class 2.2 注射用多西他赛聚合物胶束 · No verified English nameCXHL2200167 Xian Sheng Pharma Co., Ltd. romanized

18 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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