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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 187 drug applications between 19 November 2022 and 25 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 17, covering 15 drug names.

2022/11/19 – 2022/11/25

Period
2022/11/19 to 2022/11/25, 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
187
Drugs with new generic filings (by drug name, de-duplicated)
15
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

187filings, 17 of them generic

By application type

Application typeFilings
Supplement135
Generic17
New drug16
Import11
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug139
TCM25
Therapeutic biologic23

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

15 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vortioxetine Hydrobromide Tablets2110
2Dabigatran Etexilate Capsules212
3Ritonavir Tablets110
4吸入用格隆溴铵溶液 · No verified English name110
5Procaterol Hydrochloride Solution for Inhalation112
6Oxcarbazepine Oral Suspension112
7Teprenone Capsules115
8注射用泮托拉唑钠(Ⅰ) · No verified English name112
9琥珀酸呋罗曲坦片 · No verified English name110
10Dronedarone Hydrochloride Tablets114

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

84 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized58520
2Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized1140
3Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
4Shenyang San Sheng Pharmaceutical Co., Ltd. romanized510
5Xian Yang Sen Pharmaceutical Co., Ltd. romanized320
6Novartis Pharma GmbH310
7Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized310
8Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized220
9Guo Yao Group Guo Rui Pharma Co., Ltd. romanized220
10Da Li Bai Zu Zi Zhi Zhou Zhong Yao Pharmaceutical Co., Ltd. romanized220

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

29 this week

AcceptedDrugApplicants
2022/11/23New drug · Class 1 QLS12004片 · No verified English nameCXHL2200920 Qilu Pharmaceutical Co., Ltd.
2022/11/23New drug · Class 1 QLS12004片 · No verified English nameCXHL2200919 Qilu Pharmaceutical Co., Ltd.
2022/11/22Import · Class 1 MK-7684A注射液 · No verified English nameJXSL2200204 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/11/22Import · Class 2.4 Pimitespib片 · No verified English nameJXHL2200342 Taiho Pharmaceutical Co. Ltd.; Taiho Pharmaceutical of Beijing Co. Ltd.
2022/11/22Import · Class 1 IDRX-42 · No verified English nameJXHL2200341 IDRX Inc.; Choice Pharma Medical Information Consultancy(Shanghai)Co. Ltd
2022/11/22Import · Class 1 IDRX-42 · No verified English nameJXHL2200340 IDRX Inc.; Choice Pharma Medical Information Consultancy (Shanghai) Co. Ltd
2022/11/22Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202027 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2022/11/22Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2202026 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Tianjin Jin Yao Group Hebei Yong Guang Pharmaceutical Co., Ltd. romanized
2022/11/22New drug · Class 1 华通氏胶间充质干细胞注射液 · No verified English nameCXSL2200587 Shenzhen Bo Ya Gan Zhi Pharma Co., Ltd. romanized
2022/11/22New drug · Class 1 VUM02注射液 · No verified English nameCXSL2200586 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2022/11/22New drug · Class 1 注射用Zilovertamab vedotin · No verified English nameCXSL2200585 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2022/11/21Import · Class 3.1 托珠单抗注射液(皮下注射) · No verified English nameJXSS2200037 Roche Registration GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Roche(China)Holding Ltd.
2022/11/21Import · Class 1 RO7200220 注射液 · No verified English nameJXSL2200203 F. Hoffmann-La Roche Ltd
2022/11/21Import · Class 1 RO7200220 注射液 · No verified English nameJXSL2200202 F. Hoffmann-La Roche Ltd
2022/11/21Generic · Class 3 琥珀酸呋罗曲坦片 · No verified English nameCYHS2202020 Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized
2022/11/21Generic · Class 3 吸入用格隆溴铵溶液 · No verified English nameCYHL2200106 Ren He Yi Kang Group Co., Ltd. romanized
2022/11/21New drug · Class 1 洛奈利单抗注射液 · No verified English nameCXSL2200584 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2022/11/19Import · Class 1 BAY 2433334片 · No verified English nameJXHL2200339 Bayer AG; Bayer Healthcare Company Ltd.
2022/11/19Generic · Class 3 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2202017 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200915 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200914 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200913 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200912 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200911 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200910 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 BR1733片 · No verified English nameCXHL2200909 Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized
2022/11/19New drug · Class 1 BR1733片 · No verified English nameCXHL2200908 Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized
2022/11/19New drug · Class 1 KF-0210片 · No verified English nameCXHL2200907 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2022/11/19New drug · Class 1 KF-0210片 · No verified English nameCXHL2200906 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized

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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