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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 311 drug applications between 15 November 2024 and 21 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 78 drug names.

2024/11/15 – 2024/11/21

Period
2024/11/15 to 2024/11/21, 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
311
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
4

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

311filings, 99 of them generic

By application type

Application typeFilings
Supplement130
Generic99
New drug58
Unspecified12
Import7
Import re-registration4
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug246
TCM31
Therapeutic biologic26
Prophylactic biologic5
Biologic3

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2西甲硅油乳剂 · No verified English name333
3Ambroxol Hydrochloride Oral Solution3246
4Pregabalin Oral Solution315
5Tobramycin Eye Drops222
6Oxybuprocaine Hydrochloride Eye Drops2210
7Glucosamine Sulfate Capsules2251
8Acetylcysteine Granules214
9Lamotrigine Tablets210
10Piperacillin Sodium for Injection2116

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1360
2Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized650
3Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized610
4Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized440
5Bristol-Myers Squibb Australia Pty Ltd410
6Wan Bang De Pharmaceutical Group Co., Ltd. romanized330
7Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized330
8Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized333
9Janssen Research & Development LLC320
10Shanghai Pharmaceuticals Group Co., Ltd. romanized310

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

100 this week

AcceptedDrugApplicants
2024/11/21Import · Class 2.4 Adagrasib 片 · No verified English nameJXHL2400270 Mirati Therapeutics Inc. a Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/11/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2404003 Kai Feng Kang Nuo Pharma Co., Ltd. romanized
2024/11/21Generic · Class 3 Sulindac TabletsCYHS2404001 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Sulindac TabletsCYHS2404000 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2403996 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2403992 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/11/21Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2403991 Anhui Pioneer Pharmaceutical Co., Ltd
2024/11/21Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2403986 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403983 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403981 Hainan Shuang Cheng Pharma Co., Ltd. romanized
2024/11/21Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403980 Beijing Kang Er Fu Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2024/11/21Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHL2400231 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized
2024/11/21Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHL2400230 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized
2024/11/21New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSS2400125 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2024/11/21New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400120 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/11/21New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400119 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/11/21New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2400118 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2400117 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2400116 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/11/21New drug · Class 1 SPH9788片 · No verified English nameCXHL2401269 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/11/21New drug · Class 1 SPH9788片 · No verified English nameCXHL2401268 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/11/21New drug · Class 1 SPH9788片 · No verified English nameCXHL2401267 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/11/21New drug · Class 2.2 注射用硼[10B]法仑 · No verified English nameCXHL2401266 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/11/21New drug · Class 1 BPI-452080片 · No verified English nameCXHL2401265 Bei Da Pharma Co., Ltd. romanized
2024/11/21New drug · Class 1 BPI-452080片 · No verified English nameCXHL2401264 Bei Da Pharma Co., Ltd. romanized
2024/11/21New drug · Class 1 BPI-452080片 · No verified English nameCXHL2401263 Bei Da Pharma Co., Ltd. romanized
2024/11/21New drug · Class 2.2 盐酸普萘洛尔滴剂 · No verified English nameCXHL2401262 Hainan Nuo En Bio Technology Co., Ltd. romanized
2024/11/21New drug · Class 2.2 盐酸普萘洛尔滴剂 · No verified English nameCXHL2401261 Hainan Nuo En Bio Technology Co., Ltd. romanized
2024/11/21New drug · Class 2.2 ZL2301 · No verified English nameCXHL2401260 Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized
2024/11/21New drug · Class 2.2 ZL2301 · No verified English nameCXHL2401259 Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized

70 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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