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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 346 drug applications between 16 June 2022 and 22 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 33 drug names.

2022/06/16 – 2022/06/22

Period
2022/06/16 to 2022/06/22, 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
346
Drugs with new generic filings (by drug name, de-duplicated)
33
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

346filings, 50 of them generic

By application type

Application typeFilings
Supplement195
Generic50
New drug42
Import25
Unspecified18
Import re-registration16

By drug type

Drug typeFilings
Chemical drug223
TCM55
Therapeutic biologic55
Biologic9
Prophylactic biologic4

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets5320
2Minoxidil Liniment3252
3Venlafaxine Hydrochloride Sustained-Release Capsules310
4Tenofovir alafenamide Fumarate Tablets220
5Esmolol Hydrochloride Injection223
6Elagolix Tablets212
7Vonoprazan Fumarate Tablets2160
8Levetiracetam Tablets216
9Aminocaproic Acid Injection210
10注射用头孢噻肟钠他唑巴坦钠 · No verified English name211

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized19150
2Novo Nordisk A/S1020
3Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
4Henan Tong Yuan Pharmaceutical Co., Ltd. romanized990
5Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized770
6Janssen Research & Development LLC640
7Janssen-Cilag International NV620
8Lian Cardiovascular Limited510
9The Wellcome Foundation Limited510
10Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510

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

78 this week

AcceptedDrugApplicants
2022/06/22Import · Class 1 Imsidolimab注射液 · No verified English nameJXSL2200093 AnaptysBio Inc.; PPC China Corporation Limited
2022/06/22Import · Class 2.4 Setmelanotide注射液 · No verified English nameJXHL2200156 Rhythm Pharmaceuticals; Citrine Medicine (Shanghai) Co. Ltd
2022/06/22Import · Class 1 KIN-2787片 · No verified English nameJXHL2200154 Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd.
2022/06/22Import · Class 1 KIN-2787片 · No verified English nameJXHL2200153 Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd.
2022/06/22Generic · Class 3 Tranexamic Acid InjectionCYHS2200931 Hubei Duo Rui Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2022/06/22Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2200929 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2022/06/22Generic · Class 3 Aminocaproic Acid InjectionCYHS2200927 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/06/22Generic · Class 3 Aminocaproic Acid InjectionCYHS2200926 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/06/22Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200925 Guangdong Sai Feng Pharmaceuticals Technology Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2022/06/22New drug · Class 1 纳乐舒单抗注射液 · No verified English nameCXSS2200061 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2022/06/22New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2200060 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2022/06/22New drug · Class 1 JS009注射液 · No verified English nameCXSL2200285 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/06/22New drug · Class 2.2 醋酸阿比特龙软胶囊 · No verified English nameCXHL2200405 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2022/06/22New drug · Class 2.2 醋酸阿比特龙软胶囊 · No verified English nameCXHL2200404 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2022/06/22New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2200381 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/06/21Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200092 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/21Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200091 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/21Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200090 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/21Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200089 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/21Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2200157 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/21Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2200053 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2022/06/21Generic · Class 3 Elagolix TabletsCYHL2200052 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/06/21Generic · Class 3 Elagolix TabletsCYHL2200051 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/06/21Generic · Class 3 Progesterone InjectionCYHL2200050 Li Zhu Group Li Min Pharmaceutical Factory romanized
2022/06/21New drug · Class 1 伊立珠单抗注射液 · No verified English nameCXSL2200284 Bai Tai Bio Pharma Co., Ltd. romanized
2022/06/20Import · Class 1 替拉扎明注射液 · No verified English nameJXHL2200140 Raygene Inc.; Hangzhou Taibo Pharmaceutical Company Ltd.
2022/06/20New drug · Class 1.1 AC591颗粒 · No verified English nameCXZL2200029 Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized
2022/06/20New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSL2200283 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2022/06/20New drug · Class 1 CM369注射液 · No verified English nameCXSL2200282 Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized
2022/06/20New drug · Class 2.2 人干扰素α2b阴道泡腾胶囊 · No verified English nameCXSL2200281 Ke Xing Biopharmaceutical Co., Ltd. romanized

48 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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