YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 421 drug applications between 4 December 2024 and 10 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 79 drug names.

2024/12/04 – 2024/12/10

Period
2024/12/04 to 2024/12/10, 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
421
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
7

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

421filings, 121 of them generic

By application type

Application typeFilings
Supplement194
Generic121
New drug69
Import19
Unspecified11
Import re-registration5
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug272
TCM69
Therapeutic biologic68
Biologic8
In vitro diagnostic reagent2
Prophylactic biologic2

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets8460
2Lactulose Oral Solution5134
3Ambroxol Hydrochloride Oral Solution4146
4Oxcarbazepine Extended-release Tablets310
5Procaterol Hydrochloride Granules312
6Upadacitinib Sustained-release Tablets2243
7Levocarnitine Oral Solution229
8Isavuconazonium Sulfate for Injection2215
9Sodium Hyaluronate Eye Drops2230
10Mupirocin Ointment2230

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

249 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized910
2Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized880
3Jiangxi Qing Feng Pharma Co., Ltd. romanized760
4Ren He Yi Kang Group Co., Ltd. romanized732
5Ya Bao Pharma Group Co., Ltd. romanized660
6Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized645
7Shandong Xin Shi Dai Pharma Co., Ltd. romanized620
8Jiangxi Ke Lun Pharma Co., Ltd. romanized620
9Novo Nordisk A/S530
10Shaanxi Xing Bang Pharma Co., Ltd. romanized515

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

122 this week

AcceptedDrugApplicants
2024/12/10Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400235 Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd
2024/12/10Generic · Class 3 Ferrous Succinate TabletsCYHS2404279 Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd
2024/12/10Generic · Class 3 Ketamine Hydrochloride InjectionCYHS2404278 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2024/12/10Generic · Class 3 Potassium Aspartate InjectionCYHS2404277 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/12/10Generic · Class 3 Potassium Aspartate InjectionCYHS2404276 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2024/12/10Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2404260 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2024/12/10Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2404257 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/12/10Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2400252 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2024/12/10Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2400251 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 IMD101注射液 · No verified English nameCXSL2400843 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2400842 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 JS015注射液 · No verified English nameCXSL2400841 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 JS007注射液 · No verified English nameCXSL2400840 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/10New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2400839 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/12/10New drug · Class 1 9MW2821 · No verified English nameCXSL2400838 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 注射用JS207 · No verified English nameCXSL2400837 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/10New drug · Class 2.2 SYHX2011 · No verified English nameCXHS2400128 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/12/10New drug · Class 1 KPG-818胶囊 · No verified English nameCXHL2401343 Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized
2024/12/10New drug · Class 1 KPG-818胶囊 · No verified English nameCXHL2401342 Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized
2024/12/10New drug · Class 2.1; 2.2; 2.4 ADLS1026注射液 · No verified English nameCXHL2401341 Zhen Ao Jin Yin Hua Pharma Co., Ltd. romanized
2024/12/10New drug · Class 1 ADC189颗粒 · No verified English nameCXHL2401340 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized
2024/12/10New drug · Class 1 SAR107375E 片 · No verified English nameCXHL2401339 Beijing Lian Xin Pharma Co., Ltd. romanized
2024/12/10New drug · Class 1 SAR107375E 片 · No verified English nameCXHL2401338 Beijing Lian Xin Pharma Co., Ltd. romanized
2024/12/10New drug · Class 1 CS12088片 · No verified English nameCXHL2401337 Chengdu Wei Xin Pharma Co., Ltd. romanized
2024/12/10New drug · Class 2.3 RHYK2015 · No verified English nameCXHL2401336 Ren He Yi Kang Group Co., Ltd. romanized
2024/12/10New drug · Class 1 CS12088片 · No verified English nameCXHL2401335 Chengdu Wei Xin Pharma Co., Ltd. romanized
2024/12/10New drug · Class 2.3 RHYK2015 · No verified English nameCXHL2401334 Ren He Yi Kang Group Co., Ltd. romanized
2024/12/10New drug · Class 2.1; 2.2; 2.4 RFUS-301注射剂 · No verified English nameCXHL2401333 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/12/10New drug · Class 1 HRS-6213注射液 · No verified English nameCXHL2401332 Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/12/09Generic · Class 3 Zoledronic Acid InjectionCYHS2404256 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized

92 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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