YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 330 drug applications between 19 November 2024 and 25 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 79 drug names.
2024/11/19 – 2024/11/25
- New acceptances this week
- 330
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 6
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
330filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| Generic | 101 |
| New drug | 61 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| Therapeutic biologic | 42 |
| TCM | 38 |
| Prophylactic biologic | 6 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 3 | Adapalene Gel | 3 | 3 | 30 |
| 4 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | 西甲硅油乳剂 · No verified English name | 2 | 2 | 3 |
| 7 | 双氯芬酸钠贴剂 · No verified English name | 2 | 1 | 0 |
| 8 | Lamotrigine Tablets | 2 | 1 | 0 |
| 9 | 注射用阿立哌唑 · No verified English name | 2 | 1 | 4 |
| 10 | Buspirone Hydrochloride Tablets | 2 | 1 | 5 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 13 | 6 | 0 |
| 2 | Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shanxi Tong Da Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 10 | Amgen Inc. | 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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/25Generic · Class 3 | Levofloxacin InjectionCYHS2404048 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/11/25Generic · Class 3 | Thioctic Acid TabletsCYHS2404041 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/11/25New drug · Class 3.1 | 桃红四物颗粒 · No verified English nameCXZS2400035 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized |
| 2024/11/25New drug · Class 1.4 | 吸附无细胞百(三组分)白破b型流感嗜血杆菌(结合)-ACYW135群脑膜炎球菌(结合)联合疫苗 · No verified English nameCXSL2400797 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2024/11/25New drug · Class 2.2 | ZL2301 · No verified English nameCXHL2401280 | Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/25New drug · Class 1 | XH-S004片 · No verified English nameCXHL2401279 | Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized |
| 2024/11/25New drug · Class 1 | XH-S004片 · No verified English nameCXHL2401278 | Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized |
| 2024/11/25New drug · Class 2.1 | GW901肠溶软胶囊 · No verified English nameCXHL2401277 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/23Import · Class 2.2 | 罗莫索珠单抗注射液 · No verified English nameJXSL2400227 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/11/23Import · Class 1 | 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2400226 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/11/23Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2404040 | Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized |
| 2024/11/23Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2404034 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2024/11/23Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2404033 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2024/11/23Generic · Class 3 | Terlipressin Acetate InjectionCYHS2404027 | Chengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanized |
| 2024/11/23Generic · Class 3 | Tranexamic Acid and Sodium Chloride InjectionCYHS2404023 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2024/11/23Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2404018 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2024/11/23Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2404017 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2024/11/23Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2400234 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2024/11/23Generic · Class 3 | 双氯芬酸钠贴剂 · No verified English nameCYHL2400233 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/11/23Generic · Class 3 | 双氯芬酸钠贴剂 · No verified English nameCYHL2400232 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/11/23New drug · Class 2.2 | ZY-A001 · No verified English nameCXZL2400079 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2024/11/23New drug · Class 1 | 伊诺格鲁肽注射液 · No verified English nameCXSS2400129 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized |
| 2024/11/23New drug · Class 3.3 | 利妥昔单抗注射液 · No verified English nameCXSS2400128 | Hua Lan An Kang Bio Co., Ltd. romanized |
| 2024/11/23New drug · Class 3.3 | 利妥昔单抗注射液 · No verified English nameCXSS2400127 | Hua Lan An Kang Bio Co., Ltd. romanized |
| 2024/11/23New drug · Class 1 | BA1106注射液 · No verified English nameCXSL2400796 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2024/11/23New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2400795 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2024/11/23New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2400794 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2024/11/23New drug · Class 1 | AWT020注射用无菌粉末 · No verified English nameCXSL2400793 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/23New drug · Class 1 | 注射用BL-M07D1 · No verified English nameCXSL2400792 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/11/23New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2401276 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
81 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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