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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 144 drug applications between 1 February 2025 and 7 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 48 drug names.

2025/02/01 – 2025/02/07

Period
2025/02/01 to 2025/02/07, 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
144
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
8

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

144filings, 64 of them generic

By application type

Application typeFilings
Generic64
Supplement46
New drug18
Import re-registration11
Import5

By drug type

Drug typeFilings
Chemical drug119
TCM12
Therapeutic biologic12
Prophylactic biologic1

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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets7460
2Brexpiprazole Tablets3131
3Cetrorelix Acetate for Injection224
4Voglibose Tablets210
5Procaterol Hydrochloride Solution for Inhalation212
6Sodium Hyaluronate Eye Drops2130
7Imatinib Mesylate Tablets215
8Labetalol Hydrochloride Tablets213
9Minoxidil Liniment2152
10Norepinephrine Bitartrate Injection219

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

106 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bristol-Myers Squibb Pharma EEIG410
2Wuhan Jiu An Pharma Co., Ltd. romanized330
3Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized323
4Neurelis Inc.310
5Nipro Pharma Corporation310
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized310
7CSPC OUYI PHARMACEUTICAL CO., LTD.313
8Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized310
9DAIICHI SANKYO CO. LTD.220
10Shanghai Ze De Man Pharmaceuticals Technology 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

46 this week

AcceptedDrugApplicants
2025/02/07Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2500020 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/02/07Import · Class 1 ALXN2030注射液 · No verified English nameJXHL2500017 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/02/07Generic · Class 3 Methotrexate TabletsCYHS2500619 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2500618 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2025/02/07Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2500612 Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized
2025/02/07Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2500607 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2500606 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Acetylcysteine Oral SolutionCYHS2500605 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/02/07Generic · Class 3 Minoxidil LinimentCYHS2500598 Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized
2025/02/07Generic · Class 3 Minoxidil LinimentCYHS2500597 Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized
2025/02/07Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2500595 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2025/02/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2500594 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2500593 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Potassium Chloride InjectionCYHS2500588 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2500586 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2500583 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2500582 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2025/02/07Generic · Class 3 Esflurbiprofen PatchesCYHL2500032 Qilu Pharmaceutical Co., Ltd.
2025/02/07New drug · Class 1 注射用KH815 · No verified English nameCXSL2500104 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2025/02/07New drug · Class 1 注射用BL-M09D1 · No verified English nameCXSL2500103 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/02/07New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2500102 Kang Fang Pharma Co., Ltd. romanized
2025/02/07New drug · Class 2.2 YHAX · No verified English nameCXHL2500158 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2025/02/07New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500157 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/07New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500156 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/07New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500155 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/02/07New drug · Class 2.4 TAP-1503 乳膏 · No verified English nameCXHL2500154 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2025/02/06Import · Class 1 [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500015 Novartis Pharma AG
2025/02/06Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2500579 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/02/06Generic · Class 3 Sodium Nitroprusside InjectionCYHS2500578 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/02/06Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2500576 Lang Tian Pharma (Hubei) Co., Ltd. romanized

16 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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