YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 388 drug applications between 15 December 2024 and 21 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 77 drug names.
2024/12/15 – 2024/12/21
- New acceptances this week
- 388
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 3
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
388filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 171 |
| Generic | 108 |
| New drug | 68 |
| Import | 24 |
| Unspecified | 9 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 251 |
| TCM | 78 |
| Therapeutic biologic | 55 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 6 | 3 | 20 |
| 2 | Bromhexine Hydrochloride Oral Solution | 4 | 2 | 22 |
| 3 | Procaterol Hydrochloride Solution for Inhalation | 3 | 2 | 2 |
| 4 | Nafamostat Mesilate for Injection | 3 | 2 | 38 |
| 5 | Tadalafil Tablets | 3 | 1 | 23 |
| 6 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 7 | Alfacalcidol Soft Capsules | 3 | 1 | 9 |
| 8 | 阿贝西利片 · No verified English name | 3 | 1 | 2 |
| 9 | Fusidic Acid Cream | 2 | 2 | 15 |
| 10 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
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
242 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | AstraZeneca AB | 5 | 3 | 0 |
| 3 | Pfizer Inc. | 5 | 3 | 0 |
| 4 | Novartis Pharma AG | 5 | 2 | 0 |
| 5 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 9 | Novartis Europharm Limited | 4 | 2 | 0 |
| 10 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/21Import · Class 2.2 | 布西珠单抗注射液 · No verified English nameJXSS2400112 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2024/12/21Import · Class 2.2 | 布西珠单抗注射液 · No verified English nameJXSS2400111 | Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060 · No verified English nameJXHL2400299 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060 · No verified English nameJXHL2400298 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060 · No verified English nameJXHL2400297 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2404453 | Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2024/12/21Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2404450 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/21Generic · Class 3 | Potassium Phosphates InjectionCYHS2404445 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2024/12/21Generic · Class 3 | Sodium Iodide[131I] Oral SolutionCYHS2404438 | Guangdong Jun Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | PT886 · No verified English nameCXSL2400889 | Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | 注射用T320 · No verified English nameCXSL2400888 | Shanxi Na An Bio Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 2.1; 2.2; 2.4 | 注射用LX22001 · No verified English nameCXHL2401424 | Shandong Luo Xin Pharma Group Co., Ltd. romanized; Luo Xin Pharma (Shanghai) Co., Ltd. romanized |
| 2024/12/21New drug · Class 2.1; 2.2; 2.4 | 注射用LX22001 · No verified English nameCXHL2401423 | Shandong Luo Xin Pharma Group Co., Ltd. romanized; Luo Xin Pharma (Shanghai) Co., Ltd. romanized |
| 2024/12/21New drug · Class 2.2 | 注射用BSY001 · No verified English nameCXHL2401422 | Beijing Bei Sheng Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | D-2570片 · No verified English nameCXHL2401421 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | LIT0922胶囊 · No verified English nameCXHL2401420 | Li Di (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | LIT0922胶囊 · No verified English nameCXHL2401419 | Li Di (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | FNX020片 · No verified English nameCXHL2401418 | Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | FNX020片 · No verified English nameCXHL2401417 | Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | POC101胶囊 · No verified English nameCXHL2401416 | Changchun Zhang Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | POC101胶囊 · No verified English nameCXHL2401414 | Changchun Zhang Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/21New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2401411 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/20Import · Class 1 | AZD8630 · No verified English nameJXSL2400245 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/20Import · Class 1 | AZD8630 · No verified English nameJXSL2400244 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/20Import · Class 1 | AZD8630 · No verified English nameJXSL2400243 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/20Generic · Class 3 | Nimodipine Oral SolutionCYHS2404433 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2024/12/20Generic · Class 3 | Nimodipine Oral SolutionCYHS2404430 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2024/12/20Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404429 | Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/20Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404428 | Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/20Generic · Class 3 | 双氯芬酸依泊胺贴 · No verified English nameCYHS2404427 | Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
99 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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