YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 225 drug applications between 22 June 2023 and 28 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 36 drug names.
2023/06/22 – 2023/06/28
- New acceptances this week
- 225
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
225filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 111 |
| Generic | 46 |
| New drug | 46 |
| Import re-registration | 11 |
| Import | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 160 |
| TCM | 37 |
| Therapeutic biologic | 25 |
| Prophylactic biologic | 2 |
| Biologic | 1 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levofloxacin Eye Drops | 3 | 2 | 16 |
| 2 | Tadalafil Tablets | 2 | 1 | 23 |
| 3 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 4 | Perampanel Tablets | 2 | 1 | 2 |
| 5 | Cytarabine for Injection | 2 | 1 | 2 |
| 6 | Lenvatinib Mesilate Capsules | 2 | 1 | 4 |
| 7 | Phenylephrine Hydrochloride Injection | 2 | 1 | 5 |
| 8 | Rocuronium Bromide Injection | 2 | 1 | 1 |
| 9 | 阿伐替尼片 · No verified English name | 2 | 1 | 0 |
| 10 | 二甲双胍恩格列净片(Ⅵ) · No verified English name | 1 | 1 | 0 |
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
132 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | Hainan Brilliant Pharmaceutical Co., Ltd. | 7 | 3 | 3 |
| 3 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Guangxi Jin Kang Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 9 | Dr. Reddy's Laboratories Ltd. | 4 | 1 | 0 |
| 10 | Guangzhou Jia Yue Pharmaceuticals Technology 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
61 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/28Import · Class 1 | 巴托利单抗注射液 · No verified English nameJXSS2300049 | DRAGON MERIT HOLDINGS LIMITED; Samsung Biologics Co. Ltd.; Nuo Na Bio (Suzhou) Co., Ltd. romanized |
| 2023/06/28Generic · Class 3 | Pamidronate Disodium InjectionCYHS2301722 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/06/28Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2301711 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/06/28Generic · Class 3 | Hydrotalcite SuspensionCYHS2301710 | Tai Kang Hai En Pharma Co., Ltd. romanized |
| 2023/06/28New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2300012 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | EI-001注射液 · No verified English nameCXSL2300440 | An Li Xi Rong (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | DXC1002 · No verified English nameCXSL2300439 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 3.3 | 四价流感病毒亚单位疫苗 · No verified English nameCXSL2300438 | Zhong Yi An Ke Bio Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 2.2 | HZ021口溶膜 · No verified English nameCXHL2300711 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/06/28New drug · Class 2.4 | 青蒿琥酯片 · No verified English nameCXHL2300710 | Gui Lin Nan Yao Co., Ltd. romanized; Shanghai Jiao Tong University romanized |
| 2023/06/28New drug · Class 1 | MI131外用溶液 · No verified English nameCXHL2300709 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | MI131外用溶液 · No verified English nameCXHL2300708 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | MI131外用溶液 · No verified English nameCXHL2300707 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | MAX-001胶囊 · No verified English nameCXHL2300706 | An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | MAX-001胶囊 · No verified English nameCXHL2300705 | An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2023/06/28New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2300704 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/28New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2300703 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | TUL01101片 · No verified English nameCXHL2300702 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2023/06/28New drug · Class 1 | TUL01101片 · No verified English nameCXHL2300701 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2023/06/27Import · Class 2.2 | Anifrolumab注射液 · No verified English nameJXSL2300115 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/06/27Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2301702 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/06/27Generic · Class 3 | Lamivudine and Tenofovir Disoproxil Fumarate TabletsCYHS2301701 | Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized |
| 2023/06/27Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2301697 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/06/27Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2301696 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/06/27New drug · Class 1 | AHT-101注射液 · No verified English nameCXSL2300437 | Guangxi Lu Gang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/27New drug · Class 1 | LQ036单域抗体吸入用粉末 · No verified English nameCXSL2300435 | Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/27New drug · Class 1 | AK131注射液 · No verified English nameCXSL2300434 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/27New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2300433 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2023/06/27New drug · Class 1 | 注射用SHR-3032 · No verified English nameCXSL2300432 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/27New drug · Class 1.2 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300431 | Beijing Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Hua Nuo Tai Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
31 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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