YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 313 drug applications between 24 November 2023 and 30 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 65 drug names.
2023/11/24 – 2023/11/30
- New acceptances this week
- 313
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 0
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
313filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 84 |
| New drug | 44 |
| Import | 19 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 46 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 7 |
| 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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | 地氯雷他定口服溶液 · No verified English name | 3 | 1 | 26 |
| 3 | Acetylcysteine Injection | 2 | 2 | 53 |
| 4 | Cytarabine for Injection | 2 | 2 | 2 |
| 5 | Risperidone Tablets | 2 | 1 | 0 |
| 6 | 布洛芬混悬滴剂 · No verified English name | 2 | 1 | 0 |
| 7 | Torsemide Injection | 2 | 1 | 1 |
| 8 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 9 | Flumazenil Injection | 2 | 1 | 2 |
| 10 | Amisulpride Injection | 2 | 1 | 1 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 2 | CSL Behring GmbH | 7 | 1 | 0 |
| 3 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Merck Sharp & Dohme LLC | 5 | 1 | 0 |
| 6 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Qilu Pharmaceutical (Hainan) Co., Ltd | 4 | 2 | 2 |
| 9 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 3 | 3 | 3 |
| 10 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 3 | 2 | 3 |
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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/30Import · Class 1 | ALXN1850注射液 · No verified English nameJXSL2300215 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/30Import · Class 2.4 | Alectinib Hydrochloride CapsulesJXHS2300109 | Roche Registration GmbH; Excella GmbH & Co. KG; Chugai Pharma Manufacturing Co. Ltd.; Roche(China) Holding Ltd. |
| 2023/11/30Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2303319 | Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/11/30Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2303316 | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303308 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303307 | Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303306 | Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | Potassium Phosphates InjectionCYHS2303305 | Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | Thioctic Acid TabletsCYHS2303304 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303303 | Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized |
| 2023/11/30Generic · Class 3 | Thioctic Acid TabletsCYHS2303302 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2023/11/30New drug · Class 1 | 菲诺利单抗注射液 · No verified English nameCXSS2300088 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2023/11/30New drug · Class 1 | JWK001注射液 · No verified English nameCXSL2300827 | Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized |
| 2023/11/30New 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 nameCXSL2300826 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2023/11/30New drug · Class 1 | IUAb190708注射液 · No verified English nameCXSL2300825 | Ying Nuo Ou Qi Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300824 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/11/30New drug · Class 1 | SHR0302片 · No verified English nameCXHS2300108 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/11/30New drug · Class 1 | 氘恩扎鲁胺软胶囊 · No verified English nameCXHS2300107 | Hai Chuang Pharma Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2301323 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | JW202232吸入气雾剂 · No verified English nameCXHL2301322 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | JW202232吸入气雾剂 · No verified English nameCXHL2301321 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.3 | CP006吸入粉雾剂 · No verified English nameCXHL2301320 | Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | JW202232吸入气雾剂 · No verified English nameCXHL2301319 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | LN2201片 · No verified English nameCXHL2301318 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | LN2201片 · No verified English nameCXHL2301317 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/11/30New drug · Class 2.2 | LN2201片 · No verified English nameCXHL2301316 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/11/29Generic · Class 3 | Acetylcysteine InjectionCYHS2303299 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/11/29Generic · Class 3 | Salbutamol Sulfate injectionCYHS2303298 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/11/29Generic · Class 3 | Gatifloxacin Eye DropsCYHS2303293 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2023/11/29Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2303292 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
71 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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