YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 242 drug applications between 28 October 2021 and 3 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 24 drug names.
2021/10/28 – 2021/11/03
- New acceptances this week
- 242
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
242filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 27 |
| New drug | 27 |
| Import | 20 |
| Import re-registration | 16 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 169 |
| TCM | 42 |
| Therapeutic biologic | 26 |
| Prophylactic biologic | 5 |
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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 2 | Olaparib Tablets | 2 | 1 | 0 |
| 3 | Remifentanil Hydrochloride for Injection | 2 | 1 | 2 |
| 4 | Epalrestat Tablets | 1 | 1 | 1 |
| 5 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 6 | Linaclotide Capsules | 1 | 1 | 13 |
| 7 | Capecitabine Tablets | 1 | 1 | 0 |
| 8 | Folic Acid Tablets | 1 | 1 | 12 |
| 9 | Ipratropium Bromide Inhalation Solution | 1 | 1 | 2 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
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
135 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 8 | 2 | 1 |
| 3 | Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Novartis Pharma Schweiz AG | 7 | 4 | 0 |
| 5 | Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized | 6 | 2 | 0 |
| 6 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | AstraZeneca AB | 5 | 3 | 0 |
| 9 | Liu He Zhang Long Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Chongqing Duo Dai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/03Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2101029 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2021/11/03Import · Class 1 | 3D-197注射液 · No verified English nameJXSL2101123 | 3D Medicines Inc.; 3D Medicines (Shanghai) Co. Ltd. |
| 2021/11/03Import · Class 2.1 | 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101231 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute |
| 2021/11/03Import · Class 2.1 | 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101230 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute |
| 2021/11/03Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101958 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/11/03Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHL2101032 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/11/03Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHL2101031 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/11/03New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2101408 | Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized |
| 2021/11/02Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101229 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/11/02Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101228 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/11/02Generic · Class 3 | Trihexyphenidyl Hydrochloride TabletsCYHS2101959 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Dexrazoxane for InjectionCYHS2101956 | Guangdong Zhong Run Drug Research and Development Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2101939 | Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2101938 | Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Bismuth subcitrate potassium, Metronidazole and Tetracycline Hydrochloride CapsulesCYHS2101929 | Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized |
| 2021/11/02New drug · Class 1 | IBI110 · No verified English nameCXSL2101406 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/11/02New drug · Class 1 | BYS10片 · No verified English nameCXHL2101628 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized |
| 2021/11/02New drug · Class 1 | BYS10片 · No verified English nameCXHL2101627 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized |
| 2021/11/01Import · Class 1 | DS-1062a · No verified English nameJXSL2101122 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/11/01Import · Class 1 | MRTX849片 · No verified English nameJXHL2101227 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Import · Class 1 | MRTX849片 · No verified English nameJXHL2101226 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Generic · Class 3 | Tirofiban Hydrochloride InjectionCYHS2101951 | Guangzhou Man Xiang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/11/01New drug · Class 1.1 | 脑伤乐生颗粒 · No verified English nameCXZS2101005 | Shenzhen Shi Sha Song Industrial Co., Ltd. romanized; Henan Tian Fang Pharma Zhong Yao Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101405 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101404 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101403 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | GR1501注射液 · No verified English nameCXSL2101401 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101400 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | ASKG712注射液 · No verified English nameCXSL2101396 | Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101395 | Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized |
25 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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