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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 513 drug applications between 25 December 2024 and 31 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 171, covering 124 drug names.

2024/12/25 – 2024/12/31

Period
2024/12/25 to 2024/12/31, 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
513
Drugs with new generic filings (by drug name, de-duplicated)
124
Accepted this week, now under review
16

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

513filings, 171 of them generic

By application type

Application typeFilings
Supplement189
Generic171
New drug108
Import24
Unspecified16
Import re-registration5

By drug type

Drug typeFilings
Chemical drug366
TCM78
Therapeutic biologic67
Biologic1
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

124 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets7420
2Lactulose Oral Solution6334
3Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3323
4Cimetidine Injection335
5甲氧氯普胺片 · No verified English name323
6Dapagliflozin Tablets3284
7Paliperidone Palmitate Injection318
8Mirogabalin Besilate Tablets3161
9Ibrutinib Capsules229
10Isavuconazonium Sulfate for Injection2215

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

320 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized11110
2AstraZeneca AB850
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.753
4Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized730
5Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized660
6Bracco Imaging S.P.A.610
7Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized610
8Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized610
9Chengdu Easton Biopharmaceuticals Co.,Ltd.523
10Jiangsu Vanguard Pharmaceutical Co., Ltd.444

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

207 this week

AcceptedDrugApplicants
2024/12/31Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2404639 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/12/31Generic · Class 3 Tranexamic Acid and Sodium Chloride InjectionCYHS2404636 Nanjing Hai Jing Pharma Co., Ltd. romanized; Hunan Jin Jian Pharma Co., Ltd. romanized
2024/12/31Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2404631 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/31Generic · Class 3 Raltitrexed for InjectionCYHS2404628 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2024/12/31Generic · Class 3 Ferrous Succinate TabletsCYHS2404621 Hebei Long Hai Pharma Co., Ltd. romanized
2024/12/31New drug · Class 2.3 玉屏风袋泡茶 · No verified English nameCXZL2400100 Guangzhou Bai Yun Shan Chen Li Ji Pharmaceutical Factory Co., Ltd. romanized
2024/12/31New drug · Class 3.3 注射用奥马珠单抗 · No verified English nameCXSS2400143 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2024/12/31New drug · Class 1 注射用GQ1005 · No verified English nameCXSL2400932 Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/12/31New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400931 Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized
2024/12/31New drug · Class 1 PM8002注射液 · No verified English nameCXSL2400930 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2024/12/31New drug · Class 1 BNT323 · No verified English nameCXSL2400929 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2024/12/31New drug · Class 1 ZMPB-NK006注射液 · No verified English nameCXSL2400928 Hebei Mei Ou Sai Ao Jin Bio Technology Co., Ltd. romanized
2024/12/31New drug · Class 1 GO306重组溶瘤痘苗病毒注射液 · No verified English nameCXSL2400927 Shanghai Jin Si Bio Technology Co., Ltd. romanized
2024/12/31New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400926 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/12/31New drug · Class 1 人胎盘来源3D间充质干细胞注射液 · No verified English nameCXSL2400925 Guo Jian Qing Ke Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized
2024/12/31New drug · Class 1 注射用DM002 · No verified English nameCXSL2400924 Si Dao Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/12/31New drug · Class 1 注射用JS207 · No verified English nameCXSL2400923 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/31New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2400134 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2024/12/31New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2400133 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2024/12/31New drug · Class 1 SRSD216注射液 · No verified English nameCXHL2401496 Jing Yin Pharma (Shanghai) Co., Ltd. romanized
2024/12/31New drug · Class 1 IN10018片 · No verified English nameCXHL2401495 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/31New drug · Class 1 IN10018片 · No verified English nameCXHL2401494 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/12/31New drug · Class 1 EP-0186片 · No verified English nameCXHL2401493 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/12/31New drug · Class 1 EP-0186片 · No verified English nameCXHL2401492 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/12/31New drug · Class 1 CVL237片 · No verified English nameCXHL2401491 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized
2024/12/30Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400258 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/12/30Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400257 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/12/30Import · Class 1 Rilzabrutinib片 · No verified English nameJXHS2400121 Genzyme Corporation; Sanofi S.r.l; Sanofi (China) Investment Co. Ltd.
2024/12/30Generic · Class 3 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2404618 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/12/28Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2400256 Seagen Inc.; Pfizer Investment CO. Ltd.

177 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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