YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 28 June 2024 and 4 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 73 drug names.
2024/06/28 – 2024/07/04
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 8
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
370filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 198 |
| Generic | 98 |
| New drug | 40 |
| Import | 17 |
| Import re-registration | 12 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 276 |
| TCM | 49 |
| Therapeutic biologic | 38 |
| Prophylactic 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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Epalrestat Tablets | 3 | 3 | 1 |
| 2 | Bumetanide Injection | 3 | 2 | 13 |
| 3 | 地氯雷他定口服溶液 · No verified English name | 3 | 1 | 26 |
| 4 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 5 | 盐酸阿莫罗芬搽剂 · No verified English name | 2 | 2 | 15 |
| 6 | 维生素B12滴眼液 · No verified English name | 2 | 2 | 2 |
| 7 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 8 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 9 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 10 | 复方醋酸钠林格注射液 · No verified English name | 2 | 1 | 2 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Luo Yang Hao Long Pharma Co., Ltd. romanized | 17 | 8 | 0 |
| 2 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Ha Yao Group Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 1 |
| 9 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 2 | 2 |
| 10 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400159 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400158 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Bleximenib胶囊 · No verified English nameJXHL2400157 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/04Import · Class 1 | Dexpramipexole片 · No verified English nameJXHL2400156 | Areteia Therapeutics Inc.; Parexel China Co Ltd. |
| 2024/07/04Import · Class 1 | Dexpramipexole片 · No verified English nameJXHL2400155 | Areteia Therapeutics Inc.; Parexel China Co Ltd. |
| 2024/07/04Generic · Class 3 | Epalrestat TabletsCYHS2402025 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/07/04Generic · Class 3 | Pentoxifylline InjectionCYHS2402024 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2402023 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2402022 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/07/04Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2402019 | Guizhou Bo Lin Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2402018 | Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2402017 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/07/04Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2402016 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/07/04Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402015 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | Acetylcysteine InjectionCYHS2402010 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2402009 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2402008 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/07/04Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2402007 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/07/04New drug · Class 3.1 | 易黄颗粒 · No verified English nameCXZS2400025 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/07/04New drug · Class 3.3 | 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母) · No verified English nameCXSS2400063 | Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | KL-A167注射液 · No verified English nameCXSL2400426 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2400425 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | RJK-RT2831注射液 · No verified English nameCXSL2400424 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | ABSK043胶囊 · No verified English nameCXHL2400655 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | 50561片 · No verified English nameCXHL2400654 | Beijing Zhuo Kai Bio Technology Co., Ltd. romanized |
| 2024/07/04New drug · Class 2.4 | 优替德隆注射液 · No verified English nameCXHL2400653 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | HRS-2129片 · No verified English nameCXHL2400652 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/07/04New drug · Class 1 | HRS-2129片 · No verified English nameCXHL2400651 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/07/04New drug · Class 2.2; 2.4 | 磷酸氯喹凝胶 · No verified English nameCXHL2400650 | Guangzhou Kai Pu Bio Technology Co., Ltd. romanized |
| 2024/07/04New drug · Class 2.2; 2.4 | 磷酸氯喹凝胶 · No verified English nameCXHL2400649 | Guangzhou Kai Pu Bio Technology Co., Ltd. romanized |
63 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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