YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 30 November 2023 and 6 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 57 drug names.
2023/11/30 – 2023/12/06
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 1
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
301filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 71 |
| New drug | 59 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 212 |
| Therapeutic biologic | 44 |
| TCM | 38 |
| Biologic | 7 |
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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 3 | 1 | 26 |
| 2 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 5 | Risperidone Tablets | 2 | 1 | 0 |
| 6 | Folic acid injection | 2 | 1 | 1 |
| 7 | 布洛芬混悬滴剂 · No verified English name | 2 | 1 | 0 |
| 8 | Potassium Chloride Granules | 2 | 1 | 4 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Trazodone 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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 3 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 7 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 4 | 2 | 2 |
| 10 | Novartis Pharma AG | 4 | 1 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/06Import · Class 1 | Litifilimab (BIIB059) · No verified English nameJXSL2300217 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2023/12/06Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2303360 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2303359 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Potassium Chloride GranulesCYHS2303358 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Potassium Chloride GranulesCYHS2303357 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Folic acid injectionCYHS2303354 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/06Generic · Class 3 | Folic acid injectionCYHS2303353 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | TNM002注射液 · No verified English nameCXSS2300092 | Zhuhai Tai Nuo Mai Bo Pharmaceutical Co., Ltd. romanized |
| 2023/12/06New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSS2300091 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | HB0034注射液 · No verified English nameCXSL2300841 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | HB0017注射液 · No verified English nameCXSL2300840 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | XMVA09注射液 · No verified English nameCXSL2300839 | Hefei Xing Mou Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHS2300110 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/12/06New drug · Class 2.4 | 顺铂胶束注射液 · No verified English nameCXHL2301347 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301346 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301345 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301344 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301343 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | 注射用HLN601脂质体 · No verified English nameCXHL2301342 | Hong Liang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized; Yan Tai Drug Research Institute romanized |
| 2023/12/06New drug · Class 1 | CMS-D002胶囊 · No verified English nameCXHL2301341 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | CMS-D002胶囊 · No verified English nameCXHL2301340 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2023/12/06New drug · Class 1 | CMS-D002胶囊 · No verified English nameCXHL2301339 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2023/12/05Import · Class 1 | SAR443765注射液 · No verified English nameJXSL2300216 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. LTD |
| 2023/12/05Import · Class 1 | Eplontersen注射液 · No verified English nameJXHL2300301 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/05Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2303346 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/12/05Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2303344 | Fujian Tian Quan Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/12/05Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2303343 | Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2023/12/05Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303339 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2023/12/05Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303338 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2023/12/05Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303337 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
66 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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